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Showing 20 of 27412 trials
Mobile Health Program for Post-Preeclampsia Hypertension
NCT07599579
Recruiting
Conditions Hypertension (HTN), Preeclampsia, Hypert...
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

Design

Study type: Interventional Phases: Allocation: Non Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Coaching application — A digital application for providing education and support for home-based blood pressure monitoring.
  • Behavioral: Home-based blood pressure monitoring — Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
  • Other: WebMD — Smartphone-based application for health education and/or monitoring.

Primary Outcomes

  • Change in systolic blood pressure from baseline to 3 months (Baseline, 3 Months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-22
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pittsburgh
Collaborators: McKamish Family Foundation
Principal Investigators:
  • Malamo Countouris, MD, MS (PRINCIPAL_INVESTIGATOR) - University of Pittsburgh
Contact Information
Study Contact:
Amy Travis
4126413295
travisam@upmc.edu
Samantha Bryan
412-641-1363
myslinskisg@mwri.magee.edu
Interventions
  • Behavioral: Coaching application — A digital application for providing education and support for home-based blood pressure monitoring.
  • Behavioral: Home-based blood pressure monitoring — Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
  • Other: WebMD — Smartphone-based application for health education and/or monitoring.
Study Locations (1 sites)
UPMC Magee Womens Hospital, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Inclusion Criteria: * Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP. * Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication). Exclusion Criteria: * Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease). * Males will also be excluded from this study as it focuses on pregnancy related conditions. * Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.
A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
NCT07373613
Not yet recruiting
Conditions Essential Hypertension
Phase PHASE2
Enrollment 330
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: BR1400-1 — One tablet administered alone
  • Drug: BR1400-2 — One tablet administered alone
  • Drug: BR1400-3 — One tablet administered alone
  • Drug: BR1400-4 — One tablet administered alone
  • Drug: BR1400-5 — One tablet administered alone
  • Drug: BR1400-A — One tablet administered alone
  • Drug: BR1400-B — One tablet administered alone
  • Drug: BR1400-C — One tablet administered alone

Primary Outcomes

  • Change from baseline to treatment of 8 weeks in MSSBP (8 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2027-02-01
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 330 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boryung Pharmaceutical Co., Ltd
Contact Information
Study Contact:
Soo Hee Kim
+82-2-708-8000
shkim0127@boryung.co.kr
Interventions
  • Drug: BR1400-1 — One tablet administered alone
  • Drug: BR1400-2 — One tablet administered alone
  • Drug: BR1400-3 — One tablet administered alone
  • Drug: BR1400-4 — One tablet administered alone
  • Drug: BR1400-5 — One tablet administered alone
Study Locations (1 sites)
Hanyang University Hospital, Soeul, South Korea
Eligibility Criteria
Inclusion Criteria: \<Screening Visit (V1)\> Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria: * For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP \< 180 mmHg * For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP \< 180 mmHg For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study. \<Baseline Visit (V2)\> Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the baseline (Visit 2) prior to randomization meets the following criteria: * For patients without cardiovascular disease: 140 mmHg ≤ MSSBP \< 180 mmHg * For patients with cardiovascular disease, diabetes with cardiovascular disease, albuminuria, or diabetes with chronic kidney disease (CKD): 130 mmHg ≤ MSSBP \< 180 mmHg Exclusion Criteria: * Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1) and baseline(V2) * Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) * Patients with shock * Patients with orthostatic hypotension accompanied by symptoms
Dapagliflozin in Mangement of Pulmonary Hypertension Patients
NCT06612086
Not yet recruiting
Conditions Pulmonary Hypertension
Phase PHASE1
Enrollment 70
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Dapagliflozin (Forxiga) — we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

Primary Outcomes

  • Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain ) (6 month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2024-10-25
Completion: 2026-10-10
Eligibility
Age: 18 Months
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assiut University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Dapagliflozin (Forxiga) — we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient
Study Locations (1 sites)
Assiut university, Asyut, Egypt
Eligibility Criteria
Inclusion Criteria: that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older Exclusion Criteria: 1. symptomatic hypotension (systolic blood pressure \&amp;lt; 95 mmHg) 2. impaired renal function (eGFR \&amp;lt; 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \&amp;gt; 5.2 mmol/L 3. hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range 4. biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)), 5. the current use of hormone replacement therapy, chemotherapy, or immunotherapy 6. Type 1 diabetes mellitus 7. Acute pulmonary embolism (15) 8. Signficant Primary valvular Heart disease 9. Ischemic heart disease
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
NCT06246396
Recruiting
Conditions Hypertension, Resistant to Conventional ...
Phase PHASE4
Enrollment 120
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: * To what extent does minocycline lower blood pressure? * Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Drug: Minocycline Hydrochloride — Minocycline Hydrochloride 100 mg twice daily
  • Drug: Placebo — Placebo

Primary Outcomes

  • 24-h systolic blood pressure (3 months)
  • Gut microbiome (3 months)
  • Gut inflammation and leakiness (3 months)
  • Neuroinflammation (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-01-08
Completion: 2028-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Florida
Collaborators: Emory University, National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Steven M Smith, PharmD, MPH (PRINCIPAL_INVESTIGATOR) - University of Florida
Contact Information
Study Contact:
Joshua N Terrell
352-294-8297
jterrell5102@ufl.edu
David B Smith
352-294-8297
dbsmith@cop.ufl.edu
Interventions
  • Drug: Minocycline Hydrochloride — Minocycline Hydrochloride 100 mg twice daily
  • Drug: Placebo — Placebo
Study Locations (1 sites)
UF Clinical Research Center (UF CRC) - CTSI, Gainesville, Florida 32610 United States
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Uncontrolled TRH, defined as uncontrolled blood pressure (mean 24-hour ambulatory systolic BP ≥125 mm Hg or diastolic BP ≥80 mm Hg) while being adherent to a stable (no changes in ≥14 days prior) antihypertensive regimen of 3 or more drugs, including an adequately dosed diuretic or unable to tolerate a diuretic. * The participant agrees to have all study procedures performed Exclusion Criteria: * Known hypersensitivity or contraindication to minocycline or other tetracyclines * Recent (≤3 months prior), ongoing, or expected use of oral antibiotics * Estimated glomerular filtration rate (eGFR) of \<45mL/min/1.73m2, using the MDRD equation * Known secondary hypertension * History of hypertensive crisis, defined as any in-patient hospitalizations for hypertensive crisis/emergency within the past year * History of orthostatic hypotension, defined as two or more episode(s) of orthostatic hypotension (reduction of SBP of \>20 mm Hg or DBP of \>10 mm Hg within 3 minutes of standing) in the past year * History of myocardial infarction, unstable angina, syncope, or cerebrovascular accident in prior 6 months * Evidence of alcoholism or drug abuse * Severe comorbid conditions (i.e., neoplasms or HIV positive or AIDS) * Current pregnancy or anticipated pregnancy during the study.
Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes
NCT07208669
Recruiting
Conditions Blood Pressure Control
Phase NA
Enrollment 4
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. There are no guidelines for managing asymptomatically elevated BPs in the inpatient setting, and growing observational evidence suggests that antihypertensive medication intensification increases harm. The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is scientifically necessary for designing a cluster-randomized clinical trial that identifies the impact of intensification after experiencing an asymptomatically elevated BP on patient outcomes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Other: ACT-BP Intervention — In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.

Primary Outcomes

  • Primary Outcome (From date of first elevated BP reading until the end of hospitalization, assessed up to 13 months.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-11-11
Completion: 2027-07-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 4 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Elizabeth Pfoh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Elizabeth Pfoh, PhD, MPH (PRINCIPAL_INVESTIGATOR) - The Cleveland Clinic
Contact Information
Study Contact:
Elizabeth Pfoh, PhD, MPH
12162963034
pfohe@ccf.org
Interventions
  • Other: ACT-BP Intervention — In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.
Study Locations (2 sites)
Cleveland Clinic Main Campus, Cleveland, Ohio 44195 United States
Cleveland Clinic Hillcrest, Mayfield Heights, Ohio 44124 United States
Eligibility Criteria
Inclusion Criteria: * At the unit level: Medical units that do not typically care for patients requiring step-down care. Exclusion Criteria: 1. Patients less than 18 2. Patients experiencing hypertensive emergencies or cardiac symptoms 3. Patients with active cardiovascular events, such as * Stroke * Non-ST-elevation * Myocardial infarction * End-stage renal disease * Patients on dialysis * Those with acute decompensated heart failure 3\. Patients on the unit for more than 10 days 4\. Patients transferred in after being in the intensive care unit (ICU) 5\. Pregnant and post-partum women 6\. Patients discharged within 24 hours of admission 7\. Patients whose systolic BP remains below 160 mmHg during hospitalization.
Myopic Optic Neuropathy in Chinese High Myopia Population
NCT04302220
Active, positions filled
Conditions Eye Diseases
Phase Not Applicable
Enrollment 813
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Progression of glaucoma within 36 months (3 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2019-06-06
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 813 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sun Yat-sen University
Principal Investigators:
  • Xiulan Zhang, MD, PhD (PRINCIPAL_INVESTIGATOR) - Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510000 China
Eligibility Criteria
Inclusion Criteria * Age ≥18 years * Equivalent spherical ≤-6D or axial length ≥26.5mm * Best corrected visual acuity ≥ 6/12 Exclusion Criteria * Unwilling or unable to give consent, or unable to return for scheduled protocol visits. * Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease. * Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia. * Need for ocular surgery/laser or anticipated need for cataract surgery during the study period. * Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases); * Pregnant or nursing women
Medication Self-Management Technology for Older Adults
NCT07754994
Not yet recruiting
Conditions Mild Cognitive Impairment (MCI)
Phase NA
Enrollment 40
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this feasibility study is to evaluate the preliminary impact of a mobile health application (app) called bpMedManage-R, designed to support hypertension medication self-management in persons with mild cognitive impairment (PwMCI) who live alone. The main questions this study aims to answer are whether the bpMedManage-R app shows preliminary impact on medication-related self-regulation (the ability to consistently take medications as prescribed) and self-efficacy (confidence in independently managing medication use). Participants will be randomized after a baseline assessment to the bpMedManage-R Immediate Group or the bpMedManage-R Delayed Group. Participants assigned to the Immediate Group will complete a 4-week baseline adherence period, at the end of which they will enter the intervention phase. A remote training session will be conducted to initiate the intervention phase, during which participants will download the app, learn to use it, and set up their medication schedule and reminders within the app with support from the study team. They will then use the app for 8 weeks to self-manage their medications, take part in brief weekly check-ins to review progress, and complete Outcome Assessment 1 at the end of the 8-week intervention phase. Participants assigned to the Delayed Group will complete a 12-week baseline adherence period, at the end of which they will complete Outcome Assessment 1. Subsequently, they will enter the intervention phase and will follow a process similar to that of the Immediate Group. At the end of the 8-week intervention phase, they will complete Outcome Assessment 2. Researchers will compare participants who receive the bpMedManage-R app intervention immediately to those assigned to the delayed control group.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Other: Immediate Intervention Arm — Participants will first complete a 4 week baseline medication adherence monitoring period. After this period, they will attend a video conferencing session with the research team to receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks to monitor their medication adherence along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, participants will complete a final assessment.
  • Other: Delayed Intervention Arm — Participants will first complete a 12 week baseline medication adherence monitoring period. At the end of this period, they will attend a video conferencing session with the research team during which they will complete a brief assessment and receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks, along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, they will complete a final assessment.

Primary Outcomes

  • Change in Self-regulation Measured by Adapted Short Self-Regulation Questionnaire (SSRQ) (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
  • Change in Medication Usage Self-efficacy Measured by Medication Usage Self-Efficacy (MUSE) questionnaire (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
  • Change in Medication Usage Self-efficacy Measured by Medication Adherence Self-Efficacy Scale-revised (MASES-R) (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-10
Completion: 2028-06
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Illinois at Urbana-Champaign
Collaborators: Arizona State University
Contact Information
Study Contact:
Raksha Mudar
217-333-4718
raksha@illinois.edu
Interventions
  • Other: Immediate Intervention Arm — Participants will first complete a 4 week baseline medication adherence monitoring period. After this period, they will attend a video conferencing session with the research team to receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks to monitor their medication adherence along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, participants will complete a final assessment.
  • Other: Delayed Intervention Arm — Participants will first complete a 12 week baseline medication adherence monitoring period. At the end of this period, they will attend a video conferencing session with the research team during which they will complete a brief assessment and receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks, along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, they will complete a final assessment.
Eligibility Criteria
Inclusion Criteria: * Age 60+ * Fluent in English * Adequate visual and auditory acuity * Community dwelling * Lives alone * Self-reported memory problems * Manage at least one hypertension medication * Passing score on Telephone Interview for Cognitive Status - Modified (TICS- M) between 27-37 * Passing score on Montreal Cognitive Assessment (MoCA) between 20 and 26 * Geriatric Depression Scale (GDS) score of 6 or lower * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Diagnosis of dementia * Major communication difficulties
A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
NCT06948773
Active, positions filled
Conditions Primary Open Angle Glaucoma, Cataract
Phase NA
Enrollment 25
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Helix Surgical System — A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.

Primary Outcomes

  • ≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2025-05-21
Completion: 2026-09-30
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sight Sciences, Inc.
Principal Investigators:
  • Jaime Dickerson, PhD (STUDY_DIRECTOR) - Sight Sciences, Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Helix Surgical System — A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.
Study Locations (1 sites)
Panama Eye Center, Panama City, Panama
Eligibility Criteria
Inclusion Criteria: * Male or female subjects, 45 years or older * Visually significant age-related cataract. * Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months. * Diagnosed with mild to moderate primary open angle glaucoma (POAG). Exclusion Criteria: * Any of the following prior ocular procedures: * Laser trabeculoplasty ≤180 days prior to baseline * Durysta ≤12 months prior to baseline * Any implanted glaucoma device * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), * 180 days prior to baseline * Retinal laser procedure ≤3 months prior to baseline * Any form of glaucoma other than POAG * Use of topical ocular steroids. * Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol * History of penetrating keratoplasty or another corneal transplant * Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65). * Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. * BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract * BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
NCT02378259
Active, positions filled
Conditions Obesity, Diabetes, Hypertension, Steatoh...
Phase NA
Enrollment 50
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Procedure: Laparoscopic Roux-en-Y gastric bypass — Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
  • Procedure: Intense conservative treatment — Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years

Primary Outcomes

  • Body Mass Index (kg/m2) (2 years after treatment initiation)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2014-08-15
Completion: 2034-06
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Göteborg University
Collaborators: Sahlgrenska University Hospital, Karolinska University Hospital, Lund University
Principal Investigators:
  • Torsten Olbers, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Gothenburg, Dept of Surgical Sciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: Laparoscopic Roux-en-Y gastric bypass — Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
  • Procedure: Intense conservative treatment — Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years
Study Locations (3 sites)
Sahlgrenska University hospital, Gothenburg, 41345 Sweden
Skåne University Hospital, Malmö, Sweden
Karolinska University hospital, Stockholm, Sweden
Eligibility Criteria
Inclusion Criteria: * Age 13-16 years * BMI \>35 * Failed comprehensive treatment for obesity \> 1 year * Passing assessment of psychologist * Tanner 3 or more Exclusion Criteria: * Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl) * Obesity secondary to brain injury * Severely mentally disabled * Not eligible for general anesthesia * Psychotic or other major psychiatric illness * Previous major gastrointestinal surgery
Predictors of Aspirin Failure in Preeclampsia Prevention
NCT05709483
Recruiting
Conditions Preeclampsia
Phase EARLY_PHASE1
Enrollment 130
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.

Design

Study type: Interventional Phases: Early Phase1 Allocation: Non Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: None

Interventions / Regimen

  • Drug: Aspirin — Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin

Primary Outcomes

  • Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention (At study enrollment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2023-04-13
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rockefeller University
Principal Investigators:
  • Amihai Rottenstreich, MD (PRINCIPAL_INVESTIGATOR) - Rockefeller University
Contact Information
Study Contact:
Recruitment Office
1-800-782-2737
RUcares@Rockefeller.edu
Amihai Rottenstreich, MD
+1-2123277245
arottenstr@rockefeller.edu
Interventions
  • Drug: Aspirin — Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin
Study Locations (1 sites)
Rockefeller University, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18-45 years with prior history of preeclampsia who received low dose aspirin in their subsequent gestation and either did or did not have a recurrence of preeclampsia. 2. Aspirin was given in their subsequent pregnancy in a 81 mg dose prior to 16 weeks of gestation, and was taken with a self-reported compliance rate of at least 80% 3. Subsequent pregnancy lasted beyond 20 weeks of gestation 4. Willingness to abstain from non-prescription non-steroidal anti-inflammatory drugs (NSAIDs), which are known to interfere with platelet function assays, for one week prior to platelet function analyses. 5. Healthy controls recruited for SNP assay optimization: Women aged 18 years or older, with no other specific inclusion criteria that need to be met in order to be enrolled for the study. Exclusion Criteria: 1. Age \<18 years or \>45 years 2. Any clinically significant adverse reaction to aspirin on prior exposure 3. Known bleeding disorder based on personal or family history 4. History of kidney or liver impairment 5. Current pregnancy 6. Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants). 7. Chronic hypertension (systolic blood pressure \>140 mmHG or diastolic pressure \>90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician) 8. Diabetes mellitus 9. Current known malignancy 10. History of hemorrhagic stroke 11. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons 12. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation. 13. Healthy controls: A. \<18 years of age. B. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons C. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
Arm and Finger Measurement for Blood Pressure Surveillance
NCT04012151
Active, positions filled
Conditions Hypertension, Pregnancy-Induced
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Physical measurement — Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.
  • Other: Cuff size fitting — Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Primary Outcomes

  • Arm length (Left, Right) (During antenatal visit (1-2 hours). One visit only)
  • Mid Arm circumference (MAC)(Left, Right) (During antenatal visit (1-2 hours). One visit only)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2019-07-10
Completion: 2027-12-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: KK Women's and Children's Hospital
Principal Investigators:
  • Farida Ithnin, MMED (Anaes) (PRINCIPAL_INVESTIGATOR) - KK Women's and Children's Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Physical measurement — Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.
  • Other: Cuff size fitting — Fit on arm cuff and finger cuff as selected by investigators based on the measurement.
Study Locations (1 sites)
KK Women's and Children's Hospital, Singapore, 229899 Singapore
Eligibility Criteria
Inclusion Criteria: * American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation * Multiparous or nulliparous; * Age 21-50 years old; * Undergoing Caesarean section in our institution. Exclusion Criteria: * Emergent Caesarean section such that consent and measurements cannot be taken.
Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure
NCT07070583
Recruiting
Conditions Aorto Iliac Occlusive Disease, Blood Pre...
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertension is a major risk factor for a variety of cardiovascular diseases. When hypertension results from increased vascular resistance due to a narrowing of the descending aorta, it can be effectively treated with stenting. More recently, evidence suggest that stenting in more distal parts of the arterial vascular bed is also associated with a reduction in blood pressure. The investigators hypothesize that stenting of occlusions more distal of the descending aorta decreases the central blood pressure and afterload as reflected by NT-proBNP (N-terminal pro-Brain Natriuretic Peptide), a biomarker of intracardiac pressures and predictor of heart failure events. The goal of this pilot study is to prospectively investigate changes in blood pressure after stent placement in the aorto-iliac region.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Procedure: Stent placement — Patients with an aorto-iliac occlusion will receive a stent, according to standard care

Primary Outcomes

  • The primary objective is to describe the changes in arterial blood pressures between baseline and 12 months follow-up after endovascular treatment of an occlusion of the infrarenal aorta and/or common iliac arteries. (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-03-30
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rijnstate Hospital
Contact Information
Study Contact:
Michel Reijnen, prof.dr.
0031 88 005 7282
vascularsurgery@rijnstate.nl
Interventions
  • Procedure: Stent placement — Patients with an aorto-iliac occlusion will receive a stent, according to standard care
Study Locations (1 sites)
Rijnstate, Arnhem, 6815AD Netherlands
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Singed informed consent * Chronic occlusion in the infrarenal aorta and/or one or both common iliac arteries * Total lesion length of ≥30mm * Clinical indication for treatment of the pathology (Chronic limb threatening ischemia or disabling intermittent claudication not responding to supervised exercise training) Exclusion Criteria: * Patient is unable to understand the study requirements and/ or is unwilling to adhere to the follow-up * Juxtarenal pathology (\<2cm below the lowest renal artery) * Acute occlusion of the target area (Acute Leriche Syndrome) * Embolic disease
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
NCT04206852
Recruiting
Conditions Chronic Thromboembolic Pulmonary Hyperte...
Phase Not Applicable
Enrollment 200
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Procedure: Balloon pulmonary angioplasty — Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Primary Outcomes

  • Incidence of Treatment-Emergent Adverse Events of BPA procedure. (From initiation of BPA to 3-12 months after last session)
  • Change of Pulmonary artery pressure in mmHg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of cardiac index (CI) in L/m^2 caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of six minutes walk distance in meter caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of Peak VO2/kg in ml/min/kg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2018-05-11
Completion: 2028-05-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group
Contact Information
Study Contact:
Zhihong Liu, doctor
86-010-88396589
zhihongliufuwai@163.com
Interventions
  • Procedure: Balloon pulmonary angioplasty — Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
Study Locations (2 sites)
center of pulmonary vascular disease, Fuwai hospital, Beijing, 100037 China
Chinese Academy of Medical Sciences Fuwai hospital, Beijing, 100037 China
Eligibility Criteria
Inclusion Criteria: 1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH 3. Not amenable to pulmonary endarterectomy 4. Willing to provide informed consent Exclusion Criteria: 1. Patients unwilling or unable to provide written consent for participation in the study. 2. Impossible to follow up.
Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD
NCT05169021
Not yet recruiting
Conditions Cerebral Small Vessel Diseases, Stroke
Phase PHASE4
Enrollment 15000
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary objectives of this trial are: 1. Efficacy evaluation of amlodipine folic acid tablets: To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level. 2. Intensive Antihypertensive Therapy: To assess the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Drug: Amlodipine folic acid 5.8mg+intensive antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine folic acid 5.8mg+standard antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+intensive antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+standard antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

Primary Outcomes

  • All-cause stroke (including fatal and non-fatal stroke) (4 year after randomization)
  • Combined cardio-cerebrovascular events (4 year after randomization)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2021-12-31
Completion: 2028-12-31
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 15000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Tiantan Hospital
Principal Investigators:
  • Yongjun Wang (PRINCIPAL_INVESTIGATOR) - Beijing Tiantan Hospital
Contact Information
Study Contact:
Jinglin Mo
+86 18801125231
mojinglin_dmu@163.com
Anxin Wang
0086-010-59978350
anxin0907@163.com
Interventions
  • Drug: Amlodipine folic acid 5.8mg+intensive antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine folic acid 5.8mg+standard antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+intensive antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+standard antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Study Locations (1 sites)
Beijing Tiantan Hospital, Beijing, Beijing Municipality 100070 China
Eligibility Criteria
Inclusion Criteria: 1. Age 35-75 years; 2. Meets any of the following criteria: 1\) Lacunar infarction occurring within the period of seven days up to one year post-infarction, diagnosed by head MRI/CT (meeting modified Fisher criteria\*); 2)Head MRI indicating white matter hyperintensity, 4≥Fazekas score\*≥2; 3)Head MRI indicating white matter hyperintensity, Fazekas=1, combined with old subcortical vascular lacunar infarction; * For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6). 3\. Medical recorded history of hypertension. Systolic blood pressure SBP: 130-180 mm Hg on 0 or 1 medication SBP: 130-170 mm Hg on up to 2 medications SBP: 130-160 mm Hg on up to 3 medications. 4. mRS score ≤2; 5. Serum Hcy ≥10 µmol/L or MTHFR 677 TT genotype; 6. Signed informed consent form. Exclusion Criteria: 1. Patients with secondary hypertension; 2. Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%); 3. Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures; 4. Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP \<110mmHg; 5. Bilateral renal artery stenosis; 6. Patients who have previously taken candesartan or other angiotensin receptor antagonist (ARB) type medication, indapamide or other similar diuretic type medication, or any medication or health product containing folic acid, and reported adverse reactions; 7. Patients who have indicators for specific antihypertensive medications (e.g. β-blockers after acute myocardial infarction, RAS blockers for prevention of cardiovascular disease, α-blockers for treatment of benign prostate hyperplasia); 8. Within the last three months, regular usage of vitamin supplements containing folic acid, B6, or B12, or usage of folic acid antagonists (e.g. methotrexate); 9. Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²; 10. History of epilepsy or currently using anti-epileptic medication; 11. Pregnant and lactating women, or women planning to become pregnant; 12. Life expectancy less than four years; 13. Within the last month, participation in another clinical trial; 14. Any patient determined by the researchers to be unsuitable for the present study.
Assessing Peer Support for Physical Activity in Women With HIV and Hypertension
NCT07025109
Active, positions filled
Conditions HIV, Hypertension
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Peer support — Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.
  • Behavioral: Exercise Prescription — Women will be provided with an exercise prescription (Frequency, Intensity, Time, Type) which may be adjusted weekly for 6 weeks to goal of 150min/week of moderate to vigorous physical activity.
  • Behavioral: Blood pressure self monitoring — Women will receive a home blood pressure monitor and encourage to record their readings in a log.

Primary Outcomes

  • Participant attrition (From enrollment to end of 12 week intervention)
  • Intervention acceptability: Satisfaction (Mid-point (6-week) assessment and end of intervention assessment (12-week))
  • Intervention Acceptability: Treatment burden (At 6-week (mid-point intervention) and 12-weeks (end of intervention))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2026-02-06
Completion: 2026-08-31
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alabama at Birmingham
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Kaylee B Crockett, PhD (PRINCIPAL_INVESTIGATOR) - University of Alabama at Birmingham
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Peer support — Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.
  • Behavioral: Exercise Prescription — Women will be provided with an exercise prescription (Frequency, Intensity, Time, Type) which may be adjusted weekly for 6 weeks to goal of 150min/week of moderate to vigorous physical activity.
  • Behavioral: Blood pressure self monitoring — Women will receive a home blood pressure monitor and encourage to record their readings in a log.
Study Locations (1 sites)
Department of Family & Community Medicine; University of Alabama at Birmingham, Birmingham, Alabama 35205 United States
Eligibility Criteria
Inclusion Criteria: * woman living with HIV * age 40 and above * diagnosed with HTN * access to a personal phone for study-related phone calls * willing to wear an accelerometer on their waist or hip for 7 days at beginning and end of 12-week intervention * able to ambulate independently * English speaking Exclusion Criteria: * Pregnant * unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use
Pulmonary Vascular Disease Phenomics Program PVDOMICS
NCT02980887
Active, positions filled
Conditions Pulmonary Arterial Hypertension
Phase Not Applicable
Enrollment 1195
Locations 7 sites
Compensation compensation available
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

It is recognized that patients with various forms of heart and lung disease exhibit varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not well understood. Rapid advances in high throughput omic methodology, combined with powerful bioinformatics and network biology capability, have created the opportunity to conduct studies that broadly search for homologies and differences across the spectrum of disease states associated with pulmonary hypertension, and determinants of the spectrum of right ventricular compensation that accompanies these conditions

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: No Intervention — There is no intervention in this observational study

Primary Outcomes

  • Precision based definitions of pulmonary vascular diseases (PVD) (Over 5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2016-11
Completion: 2029-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 1195 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: The Cleveland Clinic
Collaborators: Brigham and Women's Hospital, Columbia University, Weill Medical College of Cornell University, Johns Hopkins University, Mayo Clinic, University of Arizona, Vanderbilt University
Principal Investigators:
  • Nicholas S Hill, MD (STUDY_CHAIR) - Tufts University Medical Center
  • Lei Xiao, MD (STUDY_DIRECTOR) - National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: No Intervention — There is no intervention in this observational study
Study Locations (7 sites)
University of Arizona Health Sciences Center, Tucson, Arizona 85721 United States
Johns Hopkins University School of Medicine, Baltimore, Maryland 21287 United States
Brigham and Women's Hospital, Boston, Massachusetts 02115 United States
Mayo Clinic, Rochester, Minnesota 55905 United States
Weill Cornell Medicine, New York, New York 10065 United States
New York Medical College, Valhalla, New York 10595 United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States
Eligibility Criteria
Cross-sectional (parent) study: Inclusion Criteria: Patients ages \>18 years of age referred for right heart catheterization for further evaluation of known PVD or to be at risk for PVD due to established cardiac disease or pulmonary disease * Able to perform complete diagnostic testing listed subsequently (cardiac catheterization, echo, exercise test, PFT's, ECG, chest CT, quality of life questionnaires, ventilation/perfusion scan, cardiac MRI, body composition bioimpedance, and sleep study) * Subject signs informed consent to perform required testing for the protocol Exclusion Criteria: Dialysis dependent renal function; In the clinician's opinion, too ill to perform the protocol testing; Pregnant or nursing Longitudinal study: Inclusion Criteria: * Any PH, comparators or control participant previously enrolled in the parent PVDOMICS protocol with a minimum of six months post-enrollment * Dialysis dependent renal function since the parent study acceptable Exclusion Criteria: Participant Level 1 (clinic visit): * Transplant other than heart or lung * In the clinician's opinion, too ill to perform L-PVDOMICS testing even if limited testing. * Participants who withdrew from the parent PVDOMICS study * Pregnant or nursing * Concurrent participation in any investigational drug study or other clinical trial Participant Level 2 (telephone visit): * Transplant other than heart or lung * Participants who withdrew from the parent PVDOMICS study Participant Level 3 (medical chart review): \- Participants who withdrew from the parent PVDOMICS study
Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa
NCT05881447
Recruiting
Conditions Chronic Kidney Diseases, Type 2 Diabetes...
Phase Not Applicable
Enrollment 1200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Chronic kidney disease (CKD) prevalence rates (18 months)
  • Prevalence of cardiovascular and non-classic risk factors of CKD (18 months)
  • Incidence of chronic kidney disease (CKD) and cardiovascular- and non-classic risk factors of CKD: (18 months)
  • Incidence of cardiovascular- and non-classic risk factors of CKD: (18 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-06-21
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Swiss Tropical & Public Health Institute
Collaborators: University Hospital, Basel, Switzerland, Ifakara Health Institute
Principal Investigators:
  • Michael Mayr, MD (PRINCIPAL_INVESTIGATOR) - University Hospital, Basel, Switzerland
  • Daniel H Paris, Prof (PRINCIPAL_INVESTIGATOR) - Swiss Tropical & Public Health Institute
  • Nikolai C Hodel, MSc (PRINCIPAL_INVESTIGATOR) - Swiss Tropical & Public Health Institute
Contact Information
Study Contact:
Nikolai C Hodel, MSc
+255762768035
nikolai.hodel@swisstph.ch
Ally Olotu, PhD
+255718927104
aolotu@ihi.or.tz
Interventions
N/A
Study Locations (1 sites)
Bagamoyo District Hospital, Bagamoyo, Coast Region Tanzania
Eligibility Criteria
Inclusion Criteria: all adult patients (≥18 years) attending the outpatients department of the Bagamoyo district hospital (BDH) or the associated Fukayosi and Yombo dispensary Exclusion Criteria: * \<18 years of age * not living in the BDH catchment area * not of African decent * not willing to come back for follow-up visits
Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women
NCT03585738
Not yet recruiting
Conditions Polycystic Ovary Syndrome
Phase NA
Enrollment 80
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS. Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited. Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in Assisted Reproductive Technology (ART) in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies. Furthermore, independently by the effect on PCOS related infertility, few data are available about the role of inositol on obstetrics outcomes of pregnancies conceived after treatment with inositol and/or orally supplemented during pregnancy. Considering that the combination of MI and DCI alleviate many of the metabolic dysregulations typical of PCOS thanks to insulin-sensitizing actions, it is plausible consider a beneficial effects on pregnancy complications such as gestational diabetes and preeclampsia.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Dietary Supplement: Inositol + Folic acid — Daily oral supplementation before spontaneous conception until delivery: Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg
  • Dietary Supplement: Folic acid — Daily oral supplementation before spontaneous conception until delivery: Folic acid: 400 mcg

Primary Outcomes

  • Gestational diabetes prevalence (During pregnancy at 16-18 week or 24-28 weeks as recommended)
  • Preeclampsia prevalence (During pregnancy after the 20 week of gestation)
  • Birth weight (At delivery.)
  • Weight gain in pregnancy (Change in weight before pregnancy and at the 38 week of gestation)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2022-01-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Università degli Studi dell'Insubria
Collaborators: Universita di Verona
Principal Investigators:
  • Antonio Simone Laganà, M.D. (PRINCIPAL_INVESTIGATOR) - Università degli Studi dell'Insubria
  • Simone Garzon, M.D. (PRINCIPAL_INVESTIGATOR) - Univerisity of Verona
  • Fabio Ghezzi, M.D. (STUDY_CHAIR) - Università degli Studi dell'Insubria
Contact Information
Study Contact:
Antonio Simone Laganà, M.D.
+39 329 6279579
antoniosimone.lagana@asst-settelaghi.it
Simone Garzon, M.D.
+39 347 0782287
simone.garzon@univr.it
Interventions
  • Dietary Supplement: Inositol + Folic acid — Daily oral supplementation before spontaneous conception until delivery: Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg
  • Dietary Supplement: Folic acid — Daily oral supplementation before spontaneous conception until delivery: Folic acid: 400 mcg
Eligibility Criteria
Inclusion Criteria: * Pregnancy spontaneously conceived in women with PCOS diagnosed by Rotterdam criteria that starts oral supplementation before conception. Exclusion Criteria: * Any kwon pre-pregnancy disease. * Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial, or until the development or pregnancy-induced/related diseases requiring pharmacological treatments.
EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION
NCT06462287
Recruiting
Conditions Apnea, Obstructive
Phase PHASE2
Enrollment 24
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Obstructive sleep apnea syndrome (OSAS) is associated with hyperaldosteronism with elevated plasma aldosterone/renin ratio, the physiopathological mechanism of which remains uncertain. This hyperaldosteronism contributes to the development of arterial hypertension and cardiovascular complications observed in patients with OSA, in particular by increasing arterial stiffness and heart rate variability. The frequent association of OSA with obesity with metabolic syndrome suggests that excess weight could be responsible for stimulation of aldosterone secretion independent of the renin/angiotensin system. Several studies indicate in particular that the production of mineralocorticoids by the adrenals could be activated by various adipocyte secretion products such as leptin and certain fatty acids after oxidation in the liver. In addition, a recent study showed that basal aldosterone secretion is also controlled by substance P released within the adrenal tissue itself by nerve fibers belonging to the splanchnic contingent. Thus, the oral administration of aprepitant, an antagonist of the substance P receptor (NK1 receptor), to healthy volunteers induces a reduction of approximately 30% in the overall secretion of aldosterone assessed by measuring aldosteronemia and 24-hour aldosteronuria. To the extent that OSA causes sympathetic hypertonia, the hypothesis is that the associated hyperaldosteronism could result from activation of the nervous control of aldosterone secretion, involving substance P and the NK1 receptor. If this is indeed the case, the administration of aprepitant to patients with OSA should result in a significant reduction in aldosteronemia.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Drug: Aprepitant 125 and 80Mg Oral Capsule — Aprepitant 1 oral capsule time a day for 4 days (First day: 125 mg and the 3 last days: 80 mg)
  • Drug: Placebo — Placebo:1 oral capsule time a day for 4 days

Primary Outcomes

  • Rate of aldosterone secretion (Immediately after the intervention/procedure/surgery)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-03-05
Completion: 2027-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Rouen
Contact Information
Study Contact:
Antoine-Guy Lopez
02 32 88 90 81
Antoine-Guy.Lopez@chu-rouen.fr
Nell Marty
02 32 88 82 65
nell.marty@chu-rouen.fr
Interventions
  • Drug: Aprepitant 125 and 80Mg Oral Capsule — Aprepitant 1 oral capsule time a day for 4 days (First day: 125 mg and the 3 last days: 80 mg)
  • Drug: Placebo — Placebo:1 oral capsule time a day for 4 days
Study Locations (1 sites)
CHU de Rouen, Rouen, France 76000 France
Eligibility Criteria
Inclusion Criteria: 1. Subject with severe obstructive sleep apnea syndrome (OSAS) defined by an apnea and hypopnea index (AHI) ≥ 30/h on polysomnography or ventilatory polygraphy (requiring continuous positive airway pressure). 2. Subject with essential hypertension treated medically or by lifestyle and dietary measures or newly diagnosed (defined by SBP ≥ 140 and/or DBP ≥ 90 mmHg according to current SFHTA-HAS recommendations). 3. Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the renin-angiotensin system), to stop consuming licorice and its derivatives, 7 to 10 days before taking the treatment. experimental and throughout the study (if applicable) Exclusion Criteria: 1. Minor subject or subject aged over 75 years 2. Criteria relating to associated pathologies leading to particular risks: * Subject presenting excessive daytime sleepiness with contraindication to driving (Epworth score \> 16) * Uncontrolled severe cardiovascular disease: myocardial infarction or stroke in the last 6 months, unstable angina, significant valvular heart disease, heart failure (≥ class II of the NYHA classification), uncontrolled cardiac arrhythmia or significant conduction abnormalities. Knowledge of chronic renal insufficiency defined by a glomerular filtration rate \< 60 mL/min/1.73m2 for more than 3 months) or moderate hepatic insufficiency defined by ALT and/or AST transaminases \> 3N) * Epilepsy * Known acute infections linked to HIV, HBV or HCV * Active cancer currently being treated 3. Contraindications to placebo and aprepitant
Mortality Outcome of Controlled Blood Pressure Participants
NCT07067632
Active, positions filled
Conditions Valid MeSH Conditions, Hypertension (HTN...
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Despite advances in antihypertensive therapy, some patients with well-controlled blood pressure still experience fatal outcomes. This paradox raises critical questions about the efficacy of blood pressure-targeted interventions and whether BP control alone ensures survival. This systematic review and meta-analysis aims to evaluate all-cause mortality and cardiovascular death among hypertensive patients who achieved BP targets in RCTs or open-label trials. To determine whether achieving controlled blood pressure through intentional intervention (pharmacological or procedural) in RCTs or open-label studies reduces mortality (all-cause and cardiovascular) in hypertensive patients.

Design

Study type: Observational Observational model: Other Time perspective: Retrospective

Interventions / Regimen

  • Drug: Antihypertensive treatment — Any intervention (pharmacological, device-based, lifestyle) intentionally directed at lowering BP Control groups receiving placebo, standard of care, or no intervention

Primary Outcomes

  • All-cause mortality (100 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2025-07-01
Completion: 2027-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: DejthidaNathaphong
Principal Investigators:
  • Nathaphong Dejthida, MD (PRINCIPAL_INVESTIGATOR) - DejthidaNathaphong
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Antihypertensive treatment — Any intervention (pharmacological, device-based, lifestyle) intentionally directed at lowering BP Control groups receiving placebo, standard of care, or no intervention
Study Locations (1 sites)
Nathaphong, Bangkok, 10110 Thailand
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years with diagnosed hypertension Blood pressure controlled at target values defined by the study (e.g., \<140/90 mmHg or \<130/80 mmHg) Any comorbidity allowed unless the study focuses on pregnancy or pediatric population Exclusion Criteria: * Observational or retrospective studies Pediatric or pregnant participants Case reports, editorials, or conference abstracts without full data Studies not reporting mortality outcomes separately for controlled BP