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Showing 20 of 25369 trials
Electrical Stimulation for Vision Neuroenhancement in Glaucoma
NCT06685211
Recruiting
Conditions Glaucoma, Glaucoma Open-Angle
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.

Design

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

Interventions / Regimen

  • Device: Eyetronic rtACS — The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.
  • Device: Sham rtACS — Participants will wear the Eyetronic system but there will be no active stimulations applied.

Primary Outcomes

  • Visual Field Index (VFI) (3 Months)
  • Mean Deviation (MD) (3 Months)
  • Pointwise Linear Regression (PLR) (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: 2025-07-14
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Collaborators: EYETRONIC, Inc
Principal Investigators:
  • Jeffrey L Goldberg, MD PhD (PRINCIPAL_INVESTIGATOR) - Stanford University
Contact Information
Study Contact:
Study Team
650-497-5942
glaucomatrials@stanford.edu
Interventions
  • Device: Eyetronic rtACS — The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.
  • Device: Sham rtACS — Participants will wear the Eyetronic system but there will be no active stimulations applied.
Study Locations (1 sites)
Byers Eye Institute at Stanford University, Palo Alto, California 94303 United States
Eligibility Criteria
Inclusion Criteria: * Participant must be at least 18. * Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). * Participant's clinical diagnosis must be consistent with primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing * Participant's eye pressure must be clinically stable, with IOP \< 18. * If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study. * Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety. Exclusion Criteria: * Participant is unable to comply with study procedures or follow-up visits. * Participant has a history of ocular herpes zoster. * Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study. * Participant has evidence of corneal opacification or lack of optical clarity. * Participant has uveitis or other ocular inflammatory disease. * Participant is receiving systemic steroids or other immunosuppressive medications. * Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration. * Participant is pregnant or lactating. * Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. * Patients with opened skull, after trepanation or with heart and brain pacemaker. * Patients with implanted intracranial metals such as clippings, coilings, ventriculo-peritoneal shunts, endoprosthesis etc. * Patients with any skin damage in the area of electrode placement. * Children and comatose patients. * Patients with recent history of epileptic seizure. * Patients with uncontrolled high levels of blood pressure (\<160 mmHg) or uncontrolled high levels of intraocular pressure (\<27 mmHg). * Patients abusing drugs or alcohol.
Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
NCT06629363
Not yet recruiting
Conditions Malignant Hypertension
Phase Not Applicable
Enrollment 1000
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as well as for identifying novel biomarkers and therapeutic targets

Design

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

Interventions / Regimen

  • Other: biobank — The following samples will be collected : * Serum samples and plasma sample: inclusion visit and follow up visit * Urines samples : inclusion visit and follow up visit * blood DNA: inclusion visit * Blood RNA: inclusion visit and follow up visit

Primary Outcomes

  • Decipher the mechanisms responsible for the transition from severe to malignant hypertension (At inclusion and 6 month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-08-01
Completion: 2036-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier de PAU
Principal Investigators:
  • Romain BOULESTREAU (PRINCIPAL_INVESTIGATOR) - University Hospital, Bordeaux
Contact Information
Study Contact:
Alice SERIS
0559726997
alice.seris@ch-pau.fr
Interventions
  • Other: biobank — The following samples will be collected : * Serum samples and plasma sample: inclusion visit and follow up visit * Urines samples : inclusion visit and follow up visit * blood DNA: inclusion visit * Blood RNA: inclusion visit and follow up visit
Eligibility Criteria
Inclusion Criteria: * patients included in the HAMA cohort with the following critera : * Malignant hypertension according to the classic definition (Severe hypertension associated with severe hypertensive retinopathy) * Severe hypertension associated with acute target organ damage due to high blood pressure Exclusion Criteria: * Refusal to participate to the substudy " HAMA bank " * patient on chronic dialysis
DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma
NCT06933836
Recruiting
Conditions Open Angle Glaucoma (OAG)
Phase Not Applicable
Enrollment 55
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.

Design

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

Interventions / Regimen

  • Device: DSLT enables newly diagnosed patients to remain well controlled and off medications — DSLT enables newly diagnosed patients to remain well controlled and off medications

Primary Outcomes

  • Success of IOP Reduction Through DSLT Utilization (12 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: 2025-03-31
Completion: 2027-12-31
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 55 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Barnet Dulaney Perkins Eye Centers
Collaborators: Alcon, a Novartis Company
Principal Investigators:
  • Christine Funke, Medical Doctor (PRINCIPAL_INVESTIGATOR) - Barnet Dulaney Perkins Eye Centers
Contact Information
Study Contact:
Derek J Arnson, Master of Education
4804201005
derek.arnson@researchavp.com
Christine Funke, Medical Doctor
4804201005
christine.funke@BDPEC.com
Interventions
  • Device: DSLT enables newly diagnosed patients to remain well controlled and off medications — DSLT enables newly diagnosed patients to remain well controlled and off medications
Study Locations (1 sites)
Barnet Dulaney Perkins Eye Centers, Mesa, Arizona 85206 United States
Eligibility Criteria
Inclusion Criteria: * Primary open angle glaucoma * Patients age 30 or greater with an IOP of 18-26 mmHg * Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines) * DSLT procedure Exclusion Criteria: * History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery * Angle closure patients * Ocular Hypertension * Baseline VF MD of worse than -12dB * Uncontrolled systemic microvascular disease (eg. HTN, DM) * Subjects with peri-limbal findings (e.g. melanosis, tumors, extensive pterygium, significant senile arcus and pterygium)
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control
NCT05917600
Not yet recruiting
Conditions Hypertension
Phase NA
Enrollment 330
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

Design

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

Interventions / Regimen

  • Other: APN intervention — Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.

Primary Outcomes

  • Blood pressure control (Medical consultation, from 2 months to 12 months after inclusion)
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: 2023-06
Completion: 2027-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 330 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Principal Investigators:
  • Jacques BLACHER, MD, PhD (PRINCIPAL_INVESTIGATOR) - Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
  • Juliette VAY-DEMOUY, MSc, PhD (STUDY_DIRECTOR) - Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
Contact Information
Study Contact:
Juliette VAY-DEMOUY, MSc, PhD student
0033142348551
juliette.vaydemouy@aphp.fr
Marie BENHAMMANI-GODARD
0033158411190
marie.godard@aphp.fr
Interventions
  • Other: APN intervention — Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.
Study Locations (1 sites)
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Paris, IDF 75004 France
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age, * Essential Hypertension * Hypertension management in Hôtel-Dieu Hospital * Ability to provide a written informed consent. Exclusion Criteria: * Have already benefited from an APN follow-up before the day of inclusion * Being under guardianship or curatorship * Pregnant patient * Beneficiary of the AME (state medical aid)
Dilapan-S®: A Multicenter US E-registry
NCT04451109
Active, positions filled
Conditions Post Term Pregnancy, Premature Rupture o...
Phase Not Applicable
Enrollment 1200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

Design

Study type: Observational Observational model: Case Only Time perspective: Retrospective

Interventions / Regimen

  • Device: Dilapan-S — Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.

Primary Outcomes

  • Rate of overall vaginal delivery (right after child delivery)
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: 2020-12-01
Completion: 2025-06-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medicem Technology s.r.o.
Collaborators: The University of Texas Medical Branch, Galveston
Principal Investigators:
  • Antonio Saad, MD (PRINCIPAL_INVESTIGATOR) - The University of Texas Medical Branch, Galveston
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Dilapan-S — Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.
Study Locations (1 sites)
The University of Texas Medical Branch, Galveston, Texas 77555 United States
Eligibility Criteria
Inclusion Criteria: * Pregnant woman whose plan of care is induction of labor * Maternal age ≥ 18 years * Gestational age ≥ 37 +0/7 weeks * Dilapan-S® used for cervical ripening Exclusion Criteria: * Data not available for extraction
Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
NCT07356375
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase Not Applicable
Enrollment 32
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary arterial hypertension (PAH) is a rare and serious condition that affects the blood vessels of the lungs and can significantly limit daily activities and quality of life. Some patients with PAH use inhaled iloprost, a medication that requires several inhalations per day, which can be difficult to maintain over time. Oral selexipag is an alternative treatment that may reduce treatment burden and improve adherence. The PROMISE study aims to evaluate how switching from inhaled iloprost to oral selexipag affects patients' quality of life, satisfaction with treatment, and adherence in real-world clinical practice. Patient-reported outcome questionnaires will be used to understand patients' perceptions of symptoms, daily functioning, and overall improvement after the transition. Adult patients with PAH who are receiving inhaled iloprost and whose physicians decide to switch treatment to oral selexipag will be followed over time. A comparison group of patients who continue using inhaled iloprost will also be observed. The study does not involve any experimental treatment or changes to routine clinical care. All medications are prescribed as part of standard medical practice. The results of this study may help improve understanding of the patient experience during treatment transitions in PAH and support more patient-centered treatment decisions.

Design

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

Interventions / Regimen

  • Drug: Selexipag — Exposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.

Primary Outcomes

  • Change in Health-Related Quality of Life (EMPHASIS-10) (From baseline (prior to transition) to 16-24 weeks of follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sao Paulo General Hospital
Principal Investigators:
  • Caio Fernandes, MD (PRINCIPAL_INVESTIGATOR) - UNIVERSIDADE SAO PAULO
Contact Information
Study Contact:
Caio Fernandes Principal Investigator, MD
+551126615034
cjcfernandes@yahoo.com.br
Interventions
  • Drug: Selexipag — Exposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.
Eligibility Criteria
Inclusion Criteria * Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension (PAH, Group 1) by right heart catheterization. * Current treatment with inhaled iloprost as part of routine clinical care. * Clinical decision by the treating physician to transition from inhaled iloprost to oral selexipag. * Ability to understand and complete patient-reported outcome questionnaires. * Provision of written informed consent. Exclusion Criteria * Significant cognitive impairment or sensory deficits that prevent completion of study questionnaires. * Unstable or decompensated comorbid conditions that may interfere with treatment adherence or study participation. * Refusal or inability to provide informed consent.
Polypills Approach for Multiple Cardiovascular Risk Factors
NCT07679828
Not yet recruiting
Conditions Hypertension, Dyslipidemia, Diabetes
Phase NA
Enrollment 8252
Locations 12 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.

Design

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

Interventions / Regimen

  • Drug: Fixed-Dose Combination Strategy — Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.

Primary Outcomes

  • 10-year CVD risk (12 months)
  • Composite cardiovascular disease outcome (36 months)
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: 2026-07-01
Completion: 2030-03-01
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 8252 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: China Medical University, China
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Fixed-Dose Combination Strategy — Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.
Study Locations (12 sites)
Affiliated Hospital of Chifeng University, Chifeng, Inner Mongolia China
Kunshan Hospital of Chinese Medicine, Kunshan, Jiangsu China
Suzhou Wujiang District Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu China
The Fifth People's Hospital of Wujiang District, Suzhou, Jiangsu China
The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu China
Taixing Second People's Hospital, Taizhou, Jiangsu China
Central Hospital of Jinzhou, Jinzhou, Liaoning China
Panjin Central Hospital, Panjin, Liaoning China
First Hospital of China Medical University, Shenyang, Liaoning China
Shengjing Hospital of China Medical University, Shenyang, Liaoning China
Eligibility Criteria
Inclusion Criteria: * Men or women * Age ≥50 years and \<75 years * Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication * Dyslipidemia, defined as LDL-C ≥1.8 mmol/L (70 mg/dL) * Type 2 diabetes with HbA1c ≥6.5% and \<12% * Willing to participate and able to sign informed consent Exclusion Criteria: * Known secondary cause of hypertension * Type 1 diabetes * Pancreatic insufficiency or diabetes secondary to pancreatitis * Triglycerides ≥5.65 mmol/L (500 mg/dL) * History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months * History of myocardial infarction or stroke within the previous 6 months * NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months * Abnormal kidney function, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m² or dialysis * Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \>3 times the upper limit of normal * Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L * Contraindication to any of the components of the polypill * Currently living with another PACIF participant * Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control * Clinical diagnosis of dementia or treatment with medications for dementia * History of malignancy * Life expectancy \<3 years * Currently participating in another intervention study * Any factors judged by the clinic team to be likely to limit adherence to interventions
Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
NCT07453030
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase Not Applicable
Enrollment 30
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Although treatments for pulmonary arterial hypertension have improved over time, patients with this specific cause of the disease are often not included in long-term studies. Selexipag is an oral medication used to treat pulmonary arterial hypertension and is part of routine clinical care in Brazil. Its long-term effects in patients with schistosomiasis-associated pulmonary arterial hypertension are not well understood. The PROPULSE-Sch study aims to evaluate long-term clinical outcomes in patients with schistosomiasis-associated pulmonary arterial hypertension who received selexipag, compared with similar patients who did not receive this medication before it became available at the study center. This is an observational study using data from routine medical care. All treatments are prescribed by the treating physicians, and participation in the study does not change patient care. The results may help improve understanding of long-term outcomes and support treatment decisions in this population.

Design

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

Primary Outcomes

  • Time to Clinical Worsening (From index date (T0) up to 36 months of follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2027-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Caio Júlio César dos Santos Fernandes
Principal Investigators:
  • Caio Fernandes, MD (PRINCIPAL_INVESTIGATOR) - UNIVERSIDADE SAO PAULO
Contact Information
Study Contact:
Caio Fernandes, Principal Investigator, MD
+551126615034
cjcfernandes@yahoo.com.br
Interventions
N/A
Study Locations (1 sites)
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo 05403-900 Brazil
Eligibility Criteria
Inclusion Criteria Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension associated with schistosomiasis (PAH-Sch). * Diagnosis of pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization, performed at any time prior to the index date (T0), as documented in the medical record. * Evidence of schistosomiasis infection, including epidemiological history and ultrasonographic findings compatible with hepatosplenic schistosomiasis. * Previous antiparasitic treatment for schistosomiasis. * Clinical stability at the index date, defined as absence of progressive right heart failure or clinical worsening within the previous 12 weeks. * World Health Organization (WHO) functional class I-III at the index date. * Stable background pulmonary arterial hypertension-specific therapy with a phosphodiesterase-5 inhibitor and/or endothelin receptor antagonist for at least 12 weeks prior to the index date. * For the treated cohort: initiation of oral selexipag as part of routine clinical care. * For the mirror cohort: eligibility for therapeutic escalation at the index date without exposure to selexipag. Exclusion Criteria * World Health Organization (WHO) functional class IV at the index date. * Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date. * Documented formal contraindication to selexipag in the medical record. * Insufficient baseline data at the index date to allow clinical characterization or inclusion in propensity score analyses.
Personalized Mobile Reminders for Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma
NCT07480577
Not yet recruiting
Conditions Primary Open-Angle Glaucoma (POAG)
Phase NA
Enrollment 84
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates whether a personalized mobile reminder program improves treatment adherence and clinical outcomes in adults with primary open-angle glaucoma (POAG) using topical antiglaucoma eye drops. Poor adherence to long-term eye-drop therapy is common in glaucoma care and may contribute to inadequate intraocular pressure (IOP) control and disease progression. Participants are randomized to either (1) a digital adherence intervention or (2) standard outpatient follow-up. The intervention consists of daily interactive SMS/WhatsApp medication reminders plus weekly brief educational messages for 3 months. The primary outcome is change in medication adherence measured by the Morisky Medication Adherence Scale-8 (MMAS-8) at month 3. Secondary outcomes include change in IOP, eye-drop instillation technique, and treatment satisfaction. Exploratory analyses assess the relationship between adherence level and OCT-based retinal nerve fiber layer (RNFL) progression metrics. The goal is to determine whether a low-cost, scalable mobile strategy can improve short-term glaucoma management in routine practice.

Design

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

Interventions / Regimen

  • Behavioral: Digital Reminder Intervention — A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.

Primary Outcomes

  • Change in Medication Adherence (Baseline and Month 3)
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: 2026-04-01
Completion: 2026-08-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sakarya Yenikent State Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Digital Reminder Intervention — A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.
Eligibility Criteria
Inclusion Criteria: Adults aged 18 to 75 years. Diagnosis of primary open-angle glaucoma (POAG) in at least one eye. Currently treated with at least one topical antiglaucoma medication. Able to read and understand study procedures and provide written informed consent. Has regular access to a mobile phone capable of receiving SMS or WhatsApp messages. Willing to comply with follow-up visits and study procedures for 3 month Exclusion Criteria: Secondary glaucoma (e.g., neovascular, uveitic, steroid-induced) or angle-closure glaucoma. Ocular surgery or laser procedure within the previous 3 months, or planned ocular surgery during study follow-up. Advanced ocular comorbidity likely to affect IOP assessment or adherence evaluation (e.g., severe corneal disease, active ocular infection/inflammation). Cognitive impairment, severe psychiatric disease, or communication barriers that prevent reliable participation. Inability to use or access mobile messaging tools required for the intervention. Participation in another interventional clinical study that may interfere with outcomes
Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy
NCT06858345
Recruiting
Conditions Preeclampsia
Phase Not Applicable
Enrollment 50
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The pharmacological treatment strategy is then tailored to the underlying hemodynamic phenotype of each patient. That is, rather than applying a one-size-fits-all treatment for all patients, therapy is tailored to the specific characteristics of how the cardiovascular system functions in each patient (e.g., whether the problem is more related to blood volume, vascular resistance, cardiac output, etc.). The goal is to personalize therapy to more effectively treat hypertensive states of pregnancy.

Design

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

Primary Outcomes

  • Prolongation of at least one week of gestation in pregnancy complicated by hypertensive state of pregnancy with antihypertensive therapy guided by hemodynamic phenotypes (Up to 40 weeks)
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: 2025-01-01
Completion: 2026-01-15
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Contact Information
Study Contact:
Catalina de Paco Matallana, MD
968369500
katy.depaco@gmail.com
Interventions
N/A
Study Locations (1 sites)
HCUVA, El Palmar, Murcia 30120 Spain
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years * Women with singleton and twin pregnancies complicated by hypertensive states of pregnancy. Exclusion Criteria: * Minors under 18 years of age. * Women with mental disabilities. * Major congenital fetal anomaly.
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
NCT05566002
Recruiting
Conditions Pulmonary Hypertension, Pulmonary Arteri...
Phase Not Applicable
Enrollment 2000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary hypertension represents a challenging and heterogeneous condition that is associated with high mortality and morbidity if left untreated. Artificial intelligence is used to study and develop theories and methods that simulate and extend human intelligence, which is being applied in fields related to cardiovascular diseases. The study intends to combine multimodal clinical data of patients who undergo right heart catheterization at Fuwai Hospital with artificial intelligence techniques to create programs that can screen and diagnose pulmonary hypertension.

Design

Study type: Observational Observational model: Case Only Time perspective: Retrospective

Interventions / Regimen

  • Diagnostic Test: Right heart catheterization — RHC is commonly used essential test to make gold-standard diagnosis of PH with mPAP \>20 mmHg. All multimodal data from patients eligible for inclusion would be randomly assigned to development datasets (70% of the study population) to train the artificial intelligence models for the detection of PH, which would be validated and tested by other datasets (30% of the study population).

Primary Outcomes

  • Accuracy of diagnosis by artificial intelligence-assisted algorithm (Baseline)
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: 2022-06-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group
Principal Investigators:
  • Zhihong Liu, MD, PhD (PRINCIPAL_INVESTIGATOR) - Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Contact Information
Study Contact:
Zhihong Liu, MD, PhD
13269276067
zhihongliufuwai@163.com
Interventions
  • Diagnostic Test: Right heart catheterization — RHC is commonly used essential test to make gold-standard diagnosis of PH with mPAP \>20 mmHg. All multimodal data from patients eligible for inclusion would be randomly assigned to development datasets (70% of the study population) to train the artificial intelligence models for the detection of PH, which would be validated and tested by other datasets (30% of the study population).
Study Locations (1 sites)
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality 100037 China
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old * Patients previously received chest X-ray, electrocardiography, echocardiography, other routine examinations, and RHC at the Fuwai Hospital, CAMS \& PUMC, Beijing, China Exclusion Criteria: * Patients without RHC * The quality of routine examinations and RHC cannot meet the requirement for further analysis * Severe loss of results of routine examinations (chest X-ray, electrocardiography, echocardiography, etc.)
REmote Physical ACtivity Intervention for High Blood Pressure Postpartum
NCT07127731
Not yet recruiting
Conditions Hypertension (HTN), Hypertension ,Pregna...
Phase NA
Enrollment 60
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this intervention is to help new mothers who had elevated blood pressure during pregnancy become more physically active after birth. The investigators will connect data from FitBits to the electronic health record. Women will then get weekly messages with feedback and goals to help them stay active. The investigators will test if the intervention improves step counts and blood pressure after pregnancy. The investigators will also test if the intervention is feasible and enjoyed by postpartum women.

Design

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

Interventions / Regimen

  • Behavioral: Patient Portal Messaging — Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits
  • Behavioral: FitBit EHR Linkage — Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)

Primary Outcomes

  • Feasibility of Recruitment (From enrollment to the end of the 24 week intervention)
  • Feasibility of Participant Retention (At study weeks 12 and 24)
  • Feasibility of FitBit+EHR linkage (From enrollment to the end of the 24 week intervention)
  • Feasibility of Intervention Messaging (From enrollment to the end of the 24 week intervention)
  • Acceptability of the Intervention (Study week 24)
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: 2027-04
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Northwestern University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
Study Contact:
Natalie A Cameron, MD, MPH
312-503-2137
natalie.cameron@northwestern.edu
Interventions
  • Behavioral: Patient Portal Messaging — Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits
  • Behavioral: FitBit EHR Linkage — Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)
Eligibility Criteria
Inclusion Criteria: * Delivery of a live birth at Northwestern Medicine 6-12 weeks prior * Systolic blood pressure 120-139 or diastolic blood pressure 80-89 during the first 20 weeks of gestation * Low self-reported physical activity levels * Able to access the internet at least weekly * Have patient portal account or willing to set one up * Willing to wear a FitBit * Spoken and written English or Spanish language fluency Exclusion Criteria: * Medical contraindications to participating in a structured physical activity program * Currently participating in a structured physical activity or weight loss program * Hypertensive disorder of pregnancy (e.g., preeclampsia, gestational hypertension, eclampsia)
A Registry Study on the "Action of Controlling Ambulatory Blood Pressure to Target in Ten Thousand Patients"
NCT03547856
Recruiting
Conditions Hypertension, Blood Pressure, Cardiovasc...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

24 hour ambulatory blood pressure (ABP) monitoring should be the first choice for diagnosis and treatment of hypertension according to European Societyof Hypertension (ESH) and the European Society of Cardiology (ESC) guideline on ambulatory blood pressure monitoring. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population. Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

Design

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

Primary Outcomes

  • Composite end point of major cardiovascular and cerebrovascular events (From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years)
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: 2018-07-18
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yan Li
Principal Investigators:
  • Yan Li (PRINCIPAL_INVESTIGATOR) - Shanghai Institute of Hypertension
Contact Information
Study Contact:
Yan Li, Professor
021-64370045
liyanshcn@yahoo.com
Interventions
N/A
Study Locations (1 sites)
Ruijin Hospital, Shanghai, Shanghai Municipality 200025 China
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years old * Clinical diagnosed hypertension with the use of antihypertensive drugs * A 24-hour ambulatory blood pressure monitoring was performed with validated equipment. * Willing to provide information about disease history and blood biochemical test data within 6 months. * Sign the informed consent Exclusion Criteria: * Without antihypertensive drug use * Hospitalized hypertension patients * Non-compliant patient
20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up
NCT02569151
Not yet recruiting
Conditions Diabetes Mellitus
Phase Not Applicable
Enrollment 600
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Participants were examined using the methods reported previous. All chemical laboratory data were obtained at each clinic visit in the morning in a non-fasting state. A single specimen at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning within 10 minutes after awakening in the sitting position, but HBP value assessed for this study used the value measured once in the same morning at each clinic visit. Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130 mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension (MN) were defined as SBP \<130 mmHg and DBP \<85 mmHg, respectively. The reason underlying that same threshold was used for both clinic and morning values was based on criteria of the 1999 WHO-International Society of Hypertension guidelines, because this study started in 1999. Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive drug use was determined in each group. In addition, based on CBP, subjects were divided into CH and CN patients. These patients were followed using the same methods used for MH and MN patients. Outcome considered only the first event in each subject. Primary end-point was death from any cause. Secondary end-points were new, worsened, or improved microvascular and macrovascular events. Risk factors related to each outcome were determined, and therapy which was added to baseline used for each disease in patients with MH was recorded at base- and end-points. All results are presented as means ± SD. Mean values were compared using the paired or unpaired student t test. To compare the prevalence of events or medical treatment in patients with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P values was used, and then hazard ratio and 95% confidence intervals were calculated. Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier survival curves and then compared by hazard rate using the log-rank test. Risk factors determined to be statistically related to outcomes were assessed by Cox proportional hazard analysis.

Design

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

Interventions / Regimen

  • Device: HBP & CBP measurement using systo 130 mmHg

Primary Outcomes

  • Death (20 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2016-04
Completion: 2027-04
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kyuzi Kamoi
Principal Investigators:
  • Kyuzi Kamoi, MD (PRINCIPAL_INVESTIGATOR) - Jyoetsu General Hospital
Contact Information
Study Contact:
Kyuzi Kamoi, MD
+81-0258-36-3968
kkam-int@echigo.ne.jp
Kyuzi Kamoi, MD
+81-0258-36-3986
kkam-int@echigo.ne.jp
Interventions
  • Device: HBP & CBP measurement using systo 130 mmHg
Eligibility Criteria
Inclusion Criteria: * Patients with type 2 diabetes mellitus Exclusion Criteria: * Patients with type 1 diabetes mellitus and with other diseases except diabetes mellitus
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
NCT04863703
Active, positions filled
Conditions Hepatitis D, Hepatitis B, Portal Hyperte...
Phase Not Applicable
Enrollment 11
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.

Design

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

Interventions / Regimen

  • Drug: Bulevirtide — Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.

Primary Outcomes

  • Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide (Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
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: 2021-05-07
Completion: 2026-12-31
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 11 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hannover Medical School
Principal Investigators:
  • Benjamin Maasoumy, MD (PRINCIPAL_INVESTIGATOR) - Hannover Medical School
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Bulevirtide — Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.
Study Locations (1 sites)
Hannover Medical School, Hanover, Lower Saxony 30625 Germany
Eligibility Criteria
Inclusion Criteria: * Chronic HBV/HDV Coinfection * suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment) * indication for antiviral treatment with Bulevirtide * age \>18years * Must be willing to participate in the study and provide written informed consent Exclusion Criteria: * patient rejects study participation * no conducted or no indication for HVPG measurement * age \<18years
Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.
NCT06823570
Recruiting
Conditions Hypertension, Vascular Function, Fitness...
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Design

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

Interventions / Regimen

  • Behavioral: Individualized exercise therapy — Patients in the intervention group will receive an individualized exercise training program 3x/week.
  • Behavioral: Lifestyle recommendations — The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Primary Outcomes

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. (From enrollment to the end of treatment after six month.)
  • Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters. (From enrollment to the end of treatment after six month.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-01
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heinrich-Heine University, Duesseldorf
Contact Information
Study Contact:
Johannes Stegbauer, Prof. Dr.
+49 211 81 080 74
Studienzentrum-Nephrologie@med.uni-duesseldorf.de
Lukas Streese, PhD
Interventions
  • Behavioral: Individualized exercise therapy — Patients in the intervention group will receive an individualized exercise training program 3x/week.
  • Behavioral: Lifestyle recommendations — The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
Study Locations (1 sites)
Universitätsklinik Düsseldorf, Düsseldorf, Düsseldorf 40225 Germany
Eligibility Criteria
Inclusion Criteria: \- systolic hypertension grade I-II (BP values \>140 mmHg to \<180 mmHg) without anti-hypertensive medication treatment Exclusion Criteria: * no written informed consent * age \<18 years * isolated diastolic hypertension * medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test) * chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (\>20 mmHg)
Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery
NCT07080229
Recruiting
Conditions Cataract, Hypertension
Phase PHASE3
Enrollment 126
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option. This study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries. Research Question: Does intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery? Research Hypothesis: Intranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo. Primary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery. Secondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness/sedation scale (MOAA/S). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively. This randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC / AHA guidelines (SBP\>140 and DBP\> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (\<50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg/kg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Intranasal dexmedetomidine — Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
  • Drug: Intranasal normal saline — Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.

Primary Outcomes

  • Mean arterial blood pressure (MAP) (From preoperative baseline until 2 hours postoperatively)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-07-16
Completion: 2026-05
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 126 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Suez Canal University
Contact Information
Study Contact:
Mohammad E Salama, MD
+201016865861
MohammadElhossieny88@med.suez.edu.eg
Abdelrhman M Alshawadfy, MD
+201091091620
abdelrhmanalshawadfy@gmail.com
Interventions
  • Drug: Intranasal dexmedetomidine — Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
  • Drug: Intranasal normal saline — Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
Study Locations (1 sites)
Suez Canal University Hospitals, Ismailia, Ismailia Governorate 41522 Egypt
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥65 years. 2. Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP \> 140 and Diastolic BP\> 90 mmHg) 3. Elective cataract surgery under local anesthesia. 4. American Society of Anesthesiologists (ASA) physical status II or III. Exclusion Criteria: 1. Allergy or contraindication to dexmedetomidine. 2. Significant baseline bradycardia (\<50 bpm) or arrhythmias. 3. Use of sedative or anxiolytic medications. 4. History of severe hepatic, renal, or cerebrovascular diseases.
Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension
NCT07603583
Recruiting
Conditions Obstructive Sleep Apnea, Hypertension
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to investigate the relationship between hypertension and obstructive sleep apnea (OSA) using heart rate variability (HRV) as a non-invasive biomarker of autonomic nervous system function. Hypertensive patients at high risk for OSA will undergo 24-hour Holter electrocardiogram monitoring to assess HRV parameters, along with overnight polysomnography (PSG) to determine OSA severity. The study will analyze the association between HRV indices and the apnea-hypopnea index (AHI), and develop predictive models using machine learning techniques. In addition, patients diagnosed with OSA will be followed after treatment, and changes in HRV and blood pressure will be evaluated to assess treatment effects and autonomic function recovery. The results of this study may provide a cost-effective and clinically applicable approach for early detection, risk stratification, and management of OSA in patients with hypertension.

Design

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

Interventions / Regimen

  • Diagnostic Test: Polysomnography — Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.

Primary Outcomes

  • Prediction of OSA Severity Using Heart Rate Variability (Baseline (at time of HRV monitoring and polysomnography))
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: 2026-04-30
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kaohsiung Armed Forces General Hospital
Principal Investigators:
  • Yung Kuo Lee, PhD (PRINCIPAL_INVESTIGATOR) - Kaohsiung Armed Forces General Hospital
Contact Information
Study Contact:
Yung Kuo Lee, PhD
+886910977485
abstyle0204@gmail.com
Chih-Hsuan Chang, MS
+886905163699
abstyle0204@gmail.com
Interventions
  • Diagnostic Test: Polysomnography — Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
Study Locations (1 sites)
Kaohsiung Armed Forces General Hospital, Kaohsiung City, Kaohsiung Taiwan
Eligibility Criteria
Inclusion Criteria: * Age 18 to 65 years * Diagnosed hypertension or resistant hypertension * STOP-Bang score ≥3 indicating high risk of obstructive sleep apnea * Willing and able to provide informed consent Exclusion Criteria: * Refusal to undergo HRV monitoring or polysomnography * Unstable medical condition that may interfere with study participation * Inability to comply with study procedures
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
NCT06616974
Active, positions filled
Conditions Pulmonary Hypertension, Heart Failure Wi...
Phase PHASE2
Enrollment 191
Locations 72 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).

Design

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

Interventions / Regimen

  • Drug: TX000045- Dose A — The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
  • Drug: TX000045- Dose B — The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
  • Drug: Placebo — The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

Primary Outcomes

  • Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). (Baseline up to Week 24 post first dose)
  • Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs. (Baseline up to Week 30 post first dose)
  • Number of participants with abnormal laboratory values and/or adverse events that are related to treatment. (Baseline up to Week 30 post first dose)
  • Number of participants with treatment-related adverse events. (Baseline up to Week 30 post first dose)
  • Number of participants with changes in the physical examination findings. (Baseline to Week 30 post first dose)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2024-09-04
Completion: 2027-01-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 191 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tectonic Therapeutic
Principal Investigators:
  • Robert Rogers, MD (STUDY_DIRECTOR) - Tectonic Therapeutic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: TX000045- Dose A — The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
  • Drug: TX000045- Dose B — The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
  • Drug: Placebo — The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Study Locations (72 sites)
Phoenix, Phoenix, Arizona 85283 United States
Scottsdale, Scottsdale, Arizona 85258 United States
San Francisco, San Francisco, California 94143 United States
Santa Rosa, Santa Rosa, California 95405 United States
Aurora, Aurora, Colorado 80045 United States
Jacksonville, Jacksonville, Florida 32216 United States
Augusta, Augusta, Georgia 30912 United States
McDonough, McDonough, Georgia 30253 United States
Boise, Boise, Idaho 83706 United States
USA, Louisville, Kentucky 40202 United States
Eligibility Criteria
Inclusion Criteria: 1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years. 2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC). 3. Has NYHA functional class II- III heart failure. 4. Has 6MWT distance from 100 to 450m. 5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening. 6. Is able to understand and provide documented consent for participation. Exclusion Criteria: 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. 2. Current or recent hospitalization prior to screening. 3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist. 4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study. 5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square. 6. Was previously administered TX000045, relaxin, or a relaxin fusion protein. 7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy. 8. Has any of the following clinical laboratory values during screening: 1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN; 2. eGFR \<30 mL/min/1.73 m2; 3. HbA1c (glycosylated hemoglobin) \>9%; 4. Platelet count \<50,000/millimeter cube; 5. Hemoglobin \<10.0g/dL; 9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045. 10. Is pregnant or breastfeeding. 11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin. 12. Has a history of drug or alcohol abuse. 13. Was recently dosed in any clinical research study.
Effectiveness of Treatments for Cirrhosis With Varicose Veins
NCT06961474
Active, positions filled
Conditions Esophageal Varices Bleeding, Portal Hype...
Phase Not Applicable
Enrollment 1900
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. Patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. Esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. Current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical interventions. However, mortality remains high, and each treatment modality has its own limitations and controversies. This study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis B, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. The study includes patients admitted for portal hypertension-related esophagogastric varices from February 2022 to December 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. Baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and Child-Pugh classification, will be collected. Follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. The primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications. The sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. Statistical analysis will be performed using SPSS 24.0 and R software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or Fisher's exact test. The study has been approved by the ethics committee, and informed consent will be obtained from all participants.

Design

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

Interventions / Regimen

  • Procedure: Endoscopic treatment — The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.

Primary Outcomes

  • Rebleeding within one year (1 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: 2022-02-01
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 1900 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Shanghai Zhongshan Hospital
Principal Investigators:
  • Shiyao Chen, Ph.D. (PRINCIPAL_INVESTIGATOR) - Shanghai Zhongshan Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: Endoscopic treatment — The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.
Study Locations (1 sites)
Zhongshan Hospital, Shanghai, Shanghai Municipality 200000 China
Eligibility Criteria
Inclusion Criteria: ① Age greater than 18 years, with no gender restriction. ② Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024. Exclusion Criteria: * Age \< 18 years ② Absence of esophageal or gastric varices ③ Incomplete medical history records