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Showing 12 of 4196 trials
Conditions Preeclampsia, Hypertensive Disorder of P...
Phase NA
Enrollment 400
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

The present study is a single-centre prospective study that will enrol pregnant women during their first trimester of pregnancy (11+0 - 13+6 weeks of gestation). During pregnancy, women will undergo standard clinical evaluation and management. During the two study visits (enrollment and 24+0 - 27+6 weeks of gestation) the investigators will perform arterial tonometry (Pulsepen) and in vivo darkfield microscopy (Glycocheck) to evaluate endothelial and vascular function. A urine sample and a blood sample for specific study analyses on metabolic profile, endothelial and angiogenic markers will be collected. Pregnancy outcomes will be collected at delivery and five years after delivery all the participants will be interview to collect long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be evaluated only in participants who will develop hypertensive disorders of pregnancy and in an equal number of controls matched for age and body mass index at the time of conception.

Design

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

Interventions / Regimen

  • Device: Arterial applanation tonometry — Arterial applanation tonometry will be performed at the carotid and femoral level by the PulsePen device (Software WPulsePen version 2.3.1, DiaTecne, Milan, Italy), while the subject is lying in the horizontal position and after 5 minutes of rest.
  • Device: In vivo endothelial glycocalyx measurement — The in vivo microscopy (GlycoCheck system) is performed in the sublingual capillaries during the morning, with the participant sitting on a chair. The sublingual capillaries are visualized using an SDF video microscope (Capiscope handheld, KK Research technology Ltd).
  • Diagnostic Test: Serum markers of angiogenesis and endothelial dysfunction — ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).
  • Diagnostic Test: Blood chemistry test — Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
  • Diagnostic Test: Serum xanthine oxidase activity — Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid

Primary Outcomes

  • Perfused Boundary Region (PBR) (Baseline visit (11/13+6 weeks of pregnancy))
  • Perfused Boundary Region (PBR) (Follow-up visit (24/27+6 weeks of pregnancy))
  • Carotid-femoral pulse wave velocity (cf-PWV) (Baseline visit (11/13+6 weeks of pregnancy))
  • Carotid-femoral pulse wave velocity (cf-PWV) (Follow-up visit (24/27+6 weeks of pregnancy))
  • Number of participants with hypertensive disorders of pregnancy (From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery)
  • Number of participants with preeclampsia (From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-01
Completion: 2031-09
Eligibility
Age: 18 Years – 65 Years
Sex: FEMALE
Volunteers: true
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: University of Bologna
Principal Investigators:
  • Arrigo Francesco Giuseppe Cicero, MD, PhD (PRINCIPAL_INVESTIGATOR) - IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
Contact Information
Study Contact:
Arrigo Francesco Giuseppe Cicero, MD, PhD
+39 051 214290
arrigo.cicero@unibo.it
Cristina Scollo, BD
cristina.scollo@aosp.bo.it
Arrigo Francesco Giuseppe Cicero, MD, PhD
+39051214290
arrigo.cicero@unibo.it
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Interventions
  • Device: Arterial applanation tonometry — Arterial applanation tonometry will be performed at the carotid and femoral level by the PulsePen device (Software WPulsePen version 2.3.1, DiaTecne, Milan, Italy), while the subject is lying in the horizontal position and after 5 minutes of rest.
  • Device: In vivo endothelial glycocalyx measurement — The in vivo microscopy (GlycoCheck system) is performed in the sublingual capillaries during the morning, with the participant sitting on a chair. The sublingual capillaries are visualized using an SDF video microscope (Capiscope handheld, KK Research technology Ltd).
  • Diagnostic Test: Serum markers of angiogenesis and endothelial dysfunction — ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).
  • Diagnostic Test: Blood chemistry test — Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
  • Diagnostic Test: Serum xanthine oxidase activity — Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid
Study Locations (1 sites)
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy, Bologna, 40124 Italy
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years * Single pregnancy * No previous pregnancies lasting more than 12 weeks * Participant willing and able to give informed consent for participation in the study Exclusion Criteria: * Intermediate-high risk of genetic abnormalities and/or need to perform invasive tests (amniocentesis, villocentesis) * History of solid organ or hematopoietic stem cell transplantation * Chronic renal failure (eGFR≤45ml/min/1.73m2) * Chronic treatment with antihypertensive drugs and/or xanthine oxidase (XO) inhibitors
Conditions Portal Hypertension, Cirrhosis
Phase Not Applicable
Enrollment 216
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows: * What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)? * Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated. * To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator. The HVPG is considered as the gold standard in this study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH.

Design

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

Interventions / Regimen

  • Diagnostic Test: ultrasound test — Conventional gray-scale ultrasound and color Doppler examination: including hepatic artery inner diameter, hepatic artery peak flow velocity, hepatic artery resistance index, portal vein trunk inner diameter, portal vein average flow velocity, spleen size, etc. STVi detection: Use the color Doppler ultrasound system (including elastic components) of Shenzhen Mindray Biomedical Electronics Co., Ltd., equipped with an abdominal convex array probe with a probe frequency of 1\~6 MHz. The probe was placed in a supine position or slightly tilted to the left, with the right arm raised and fully abducted to increase the width of the intercostal space, and the liver viscoelastic index of the right lobe of the liver was measured between the intercostals. During measurement, the subject should hold his breath for 3 to 5 seconds in a calm state. Do not hold his breath after taking a deep breath. The sampling frame should be placed in a place with uniform echo in the liver parenchyma, avoiding large

Primary Outcomes

  • The STVi index (baseline, pre-intervention)
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: 2024-09-02
Completion: 2027-09-30
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 216 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University
Contact Information
Study Contact:
Shihao Xu, doctor
+86 13857766918
dcxshvip@wmu.edu.cn
Shihao Xu, doctor's degree
13857766918
dcxshvip@wmu.edu.cn
the First Affiliated Hospital of Wenzhou Medical University
Shihao Xu
the First Affiliated Hospital of Wenzhou Medical University
Interventions
  • Diagnostic Test: ultrasound test — Conventional gray-scale ultrasound and color Doppler examination: including hepatic artery inner diameter, hepatic artery peak flow velocity, hepatic artery resistance index, portal vein trunk inner diameter, portal vein average flow velocity, spleen size, etc. STVi detection: Use the color Doppler ultrasound system (including elastic components) of Shenzhen Mindray Biomedical Electronics Co., Ltd., equipped with an abdominal convex array probe with a probe frequency of 1\~6 MHz. The probe was placed in a supine position or slightly tilted to the left, with the right arm raised and fully abducted to increase the width of the intercostal space, and the liver viscoelastic index of the right lobe of the liver was measured between the intercostals. During measurement, the subject should hold his breath for 3 to 5 seconds in a calm state. Do not hold his breath after taking a deep breath. The sampling frame should be placed in a place with uniform echo in the liver parenchyma, avoiding large
Study Locations (1 sites)
the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325006 China
Eligibility Criteria
Inclusion Criteria: * Age older than 18 years. * Clinically diagnosed with cirrhosis. Meeting the diagnostic criteria of the 2019 edition of the "Cirrhosis Diagnosis and Treatment Guidelines": (1) Histology consistent with cirrhosis diagnosis; (2) Endoscopy shows esophageal gastric varices or ectopic varices, excluding non-cirrhotic portal hypertension; (3) Imaging examinations such as ultrasound, LSM, or CT suggest features of cirrhosis or portal hypertension: such as splenomegaly, portal vein ≥1.3 cm, LSM measurements meeting diagnostic thresholds for cirrhosis of different etiologies; (4) In the absence of histology, endoscopy, or imaging examinations, the following abnormal indicators suggest the presence of cirrhosis (must meet 2 of the 4 criteria): a. PLT \<100×10\^9/L, with no other explanations; b. Serum ALB \<35 g/L, excluding malnutrition or other causes such as renal disease; c. INR \>1.3 or prolonged PT (discontinuation of thrombolytics or anticoagulants for \>7 days); d. AST/PLT ratio index (APRI): Adult APRI score \>2, with attention to the influence of hepatotoxic drugs and other factors on APRI. * Planning to undergo HVPG testing and meeting the indications for HVPG testing in the "Chinese Expert Consensus on the Clinical Application of Hepatic Venous Pressure Gradient (2018 edition)" : (1) Assessing the efficacy of drug therapy for primary and secondary prevention of esophageal gastric variceal bleeding; (2) Predicting the risk of esophageal gastric variceal bleeding and guiding treatment plan selection; (3) Predicting the risk, degree of progression, and clinical prognosis of decompensated events in cirrhosis; (4) Evaluating the efficacy of related new drugs; (5) Evaluating the accuracy of related non-invasive techniques; (6) Diagnosis and differential diagnosis of portal hypertension types. * Able to understand and voluntarily sign a written informed consent form. Exclusion Criteria: * Post-TIPS procedure; * Post-hepatectomy splenectomy; * Hepatic malignancy; * Portal vein thrombosis; * Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction; * Pregnant and postpartum women.
Conditions Preeclampsia
Phase EARLY_PHASE1
Enrollment 130
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
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 – 45 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
Amihai Rottenstreich, MD
212-327-7245
arottenstr@rockefeller.edu
Rockefeller University
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.
Conditions Preterm Birth, Preeclampsia
Phase PHASE1, PHASE2
Enrollment 400
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Single

Interventions / Regimen

  • Drug: Daily aspirin (ASA) — 162mg aspirin taken daily
  • Drug: Split dose aspirin (ASA) — 81mg aspirin q12hours

Primary Outcomes

  • Aspirin Response PFA-100 epinephrine closure time (seconds) (2-4 weeks after aspirin initiation)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-06-26
Completion: 2029-12-31
Eligibility
Age: 16 Years – 55 Years
Sex: FEMALE
Volunteers: false
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Thomas Jefferson University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact Information
Study Contact:
Rupsa C Boelig, MD
215-955-5000
rupsa.boelig@jefferson.edu
Rupsa C Boelig, MD
215-955-5000
rupsa.boelig@jefferson.edu
Thomas Jefferson University
Brandy Firman
brandy.firman@jeffereson.edu
Thomas Jefferson University
Interventions
  • Drug: Daily aspirin (ASA) — 162mg aspirin taken daily
  • Drug: Split dose aspirin (ASA) — 81mg aspirin q12hours
Study Locations (1 sites)
Thomas Jefferson University, Philadelphia, Pennsylvania 19060 United States
Eligibility Criteria
Inclusion Criteria * Singleton gestation gestational age \<16 0/7 weeks, dating confirmed with ultrasound * ≥1 high risk factor for preeclampsia or ≥2 moderate risk factors as per United States Preventative Services Task Force (2021) * Recommendation for 162mg aspirin daily in pregnancy * Age 16-55 years old Exclusion criteria * Contraindication to aspirin * Current or planned use of any other anticoagulation * Thrombocytopenia, other known platelet or bleeding disorder * Abnormally elevated baseline PFA-100 epinephrine closure time prior to aspirin initiation
Conditions Pulmonary Hypertension
Phase NA
Enrollment 20
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Design

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

Interventions / Regimen

  • Device: Gradient Denervation System — The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Primary Outcomes

  • Device related serious adverse events (30-days post-treatment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-26
Completion: 2026-06-30
Eligibility
Age: 22 Years – 85 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Gradient Denervation Technologies
Principal Investigators:
  • Julie Etheridge (STUDY_DIRECTOR) - Gradient
Contact Information
Study Contact:
Julie Etheridge
+49 16094434355
clinical@gradientdenervation.com
Julie Etheridge
clinical@gradientdenervation.com
Hospital Universitari Germans Trias i Pujol
Julie Etheridge
clinical@gradientdenervation.com
Hospital Universitari Vall d'Hebron
Interventions
  • Device: Gradient Denervation System — The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Study Locations (3 sites)
Hospital Universitari Germans Trias i Pujol, Badalona, 08916 Spain
Hospital Universitari Vall d'Hebron, Barcelona, 08035 Spain
Hospital Clínico Universitario de Valencia, Valencia, Spain
Eligibility Criteria
Inclusion Criteria: * Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest * Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest * Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise * NYHA Class II or III * Glomerular Filtration Rate (GFR) ≥ 25 ml/min Exclusion Criteria: * Unwilling to provide informed consent or complete follow-up assessments * Life expectancy of \< 2 years * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Unable to tolerate right heart catheterization * Severe aortic, mitral or pulmonary valve regurgitation * Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery) * Systemic infection or localized infection/rash at planned access site at time of procedure * CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months
Conditions Preeclampsia (PE) Risk, Preeclampsia
Phase Not Applicable
Enrollment 1430
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Preeclampsia is a hypertensive pregnancy disorder that can quickly lead to serious, potentially life-threatening outcomes for both the mother and the fetus. Typical features of preeclampsia are by endothelial and microvascular dysfunctionsNotably, such impairments in endothelial function may precede preeclampsia diagnosis and canpersist for years postpartum. In clinical practice, however, no predictive methods have yet been established that specifically reflect endothelial dysfunction in the context of preeclampsia. Hyperspectral imaging represents a new and non-invasive imaging modality that allows contact-free visualization of peripheral microcirculatory dynamics and tissue perfusion. Despite its growing use in other medical fields, this technology has not yet been systematically studied to determine its predictive potential in preeclampsia. The HIPPA project (Systematic Evaluation of Hyperspectral Analysis for Prediction of Preeclampsia) is a prospective observational study to evaluate the applicability of hyperspectral imaging as a new tool for prediction of preeclampsia.

Design

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

Primary Outcomes

  • Number of patients with Preeclampsia (up to one week after delivery)
  • Risk ratio of the preeclampsia screening (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: 2025-08-21
Completion: 2027-07-01
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: true
Enrollment: 1430 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heidelberg University
Principal Investigators:
  • Dr. med. Alexandra von Au (PRINCIPAL_INVESTIGATOR) - University Heidelberg
Contact Information
Study Contact:
Anna S Dr. med. Anna Scholz, MD
+49 6221 56 32080
anna.scholz@med.uni-heidelberg.de
Alexandra von Au, MD
Dr. med. Anna Scholz
+49 6221 56 32080
anna.scholz@med.uni-heidelberg.de
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Interventions
N/A
Study Locations (1 sites)
Heidelberg University Hospital, Department of Gynecology and Obstetrics, Heidelberg, 69120 Germany
Eligibility Criteria
Inclusion Criteria: * singleton pregnancies * age ≥ 18 years * patient's ability to provide consent * written informed consent * women scheduled for a routine ultrasound scan in first or second trimester Exclusion Criteria: * lack of consent * language barrier * severe fetal chromosomal/genetic/structural anomalies known at study enrollment * smoking in the last two hours before measurement * diagnosis of preeclampsia at study enrollment
Conditions Pulmonary Hypertension
Phase Not Applicable
Enrollment 900
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg measured in the right heart catheterization. There are different forms of PH defined in the classification of Dana Point 2008. PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like the echocardiography, stress echocardiography and cardio pulmonary exercise testing. In the diagnosis process and in the follow up of PH patients biomarkers like NTproBNP are helpful. There are no specific biomarkers for the disease which can make the diagnosis process easier and predict prognosis. The systematic data collection in a data base provides better information about patients in daily routine and clinical studies as well as in the design of new studies.

Design

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

Primary Outcomes

  • Collecting data in a PH patient database (After one year: first analysis of retrospectively collected data. Ongoing data collection: new data of patients who are already in the database, new patients (3-4 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: 2010-07
Completion: 2027-07
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 900 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical University of Graz
Principal Investigators:
  • Horst Olschewski, MD (PRINCIPAL_INVESTIGATOR) - Medical University of Graz
Contact Information
Study Contact:
Horst Olschewski, MD
+43-316-385-12183
horst.olschewski@medunigraz.at
Maria Tscherner, MD
+43-316-385-12183
m.tscherner@medunigraz.at
Horst Olschewski, MD
+43-316-385-12183
horst.olschewski@medunigraz.at
Medical University of Graz
Interventions
N/A
Study Locations (1 sites)
Medical University of Graz, Graz, 8010 Austria
Eligibility Criteria
Inclusion Criteria: * patients with pulmonary hypertension * patients at risk for getting pulmonary hypertension * patients who have symptoms which my be due to pulmonary hypertension when we have their written informed consent. Exclusion Criteria: * patients without written informed consent
Conditions Portal Hypertension, Hepatic Decompensat...
Phase PHASE4
Enrollment 474
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria. The main question it aims to answer is: Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment. Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality. Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations, including blood tests, ultrasonography of the liver, upper gastrointestinal endoscopy, transient elastography.

Design

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

Interventions / Regimen

  • Drug: Carvedilol — Patients in the NSBB arm will receive generic carvedilol. The starting dose of oral carvedilol is 6.25mg daily (to be taken once or twice per day) and can be adjusted at each scheduled visit (either by increasing the dosage or frequency of dose administration) according to patients' tolerance, as well as the blood pressure and pulse rate that the systolic blood pressure should be not lower than 90 mmHg and pulse rate not lower than 55 beats per minute. The dosage of carvedilol can also be titrated or discontinued at unscheduled visit according to patient's condition. In case carvedilol is discontinued, it can be resumed from the starting dose at next scheduled visit if there is no contraindication for carvedilol. The dose of carvedilol will be kept at 6.25-12.5mg per day unless there are additional non-hepatic indications such as arterial hypertension or cardiac disease warranting higher carvedilol dosage. The maximum allowed dose of carvedilol is 50mg daily as per drug instruction.

Primary Outcomes

  • composite of incident high-risk varices (HRV), hepatic decompensation or death (5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-07-17
Completion: 2031-07-30
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 474 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Collaborators: University of Malaya, Royal Prince Alfred Hospital, Sydney, Australia, Ruijin Hospital, E-DA Hospital, Asian Institute of Gastroenterology, India
Principal Investigators:
  • Jimmy Che-To Lai, MB ChB (PRINCIPAL_INVESTIGATOR) - Chinese University of Hong Kong
Contact Information
Study Contact:
Angel Chim, MSc
+852 3505 4205
angelchim@cuhk.edu.hk
Jimmy Che-To Lai
jimmyctlai@cuhk.edu.hk
Prince of Wales Hospital, The Chinese University of Hong Kong
Interventions
  • Drug: Carvedilol — Patients in the NSBB arm will receive generic carvedilol. The starting dose of oral carvedilol is 6.25mg daily (to be taken once or twice per day) and can be adjusted at each scheduled visit (either by increasing the dosage or frequency of dose administration) according to patients' tolerance, as well as the blood pressure and pulse rate that the systolic blood pressure should be not lower than 90 mmHg and pulse rate not lower than 55 beats per minute. The dosage of carvedilol can also be titrated or discontinued at unscheduled visit according to patient's condition. In case carvedilol is discontinued, it can be resumed from the starting dose at next scheduled visit if there is no contraindication for carvedilol. The dose of carvedilol will be kept at 6.25-12.5mg per day unless there are additional non-hepatic indications such as arterial hypertension or cardiac disease warranting higher carvedilol dosage. The maximum allowed dose of carvedilol is 50mg daily as per drug instruction.
Study Locations (1 sites)
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: * Aged 18 years of above * Established diagnosis of chronic liver disease(s) of the following etiologies * Alcohol-related liver disease (ARLD) * Chronic hepatitis B (CHB) * Chronic hepatitis C (CHC) * Metabolic dysfunction-associated steatotic liver disease (MASLD) § Non-obese (BMI \<30kg/m2) and obese (BMI ≥30 kg/m2) * In high-risk grey zone or CSPH, by Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) or ANTICIPATE-NASH model (for obese MASLD) within 6 months from screening * Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) * LSM ≥25 kPa (CSPH) * LSM ≥20 kPa - \<25 kPa and platelet count \<150 x 10\^9/L; or LSM ≥15 kPa - \<20 kPa and platelet count \<110 x 10\^9/L (high-risk grey zone) * ANTICIPATE-NASH model (for obese MASLD) * Predictive probability for CSPH \>90% (CSPH) * Predictive probability for CSPH ≥60% - \<90% (high-risk grey zone) Exclusion Criteria: * Presence of high-risk varices (HRV) (i.e. moderate to large oesophageal varices \[OV\] or OV with red wale sign) found in OGD * Current use of non-selective beta-blocker (NSBB) or any use of NSBB within 6 months before * Use of selective beta blocker, such as atenolol or metoprolol, is not excluded * Selective beta-blocker will be switched to carvedilol in NSBB arm, and will be kept unchanged in conventional arm if there is clinical need for the selective beta-blocker * Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100 mmHg, asthma, poorly controlled chronic obstructive pulmonary disease, and peripheral vascular disease) * Current use of nitrated drugs or any use of nitrated drugs within 6 months before o Use of sublingual nitrate, such as glyceryl trinitrate, is not excluded * Contraindication to OGD (e.g. Intestinal perforation or obstruction) * Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome) o Child's B cirrhosis without decompensating events is not excluded * Current or history of hepatocellular carcinoma (HCC) * Current or history of portal vein thrombosis * Transjugular intrahepatic portosystemic shunt (TIPS) * Liver transplantation * Serious medical illness with limited life expectancy of less than 6 months * Pregnancy * Unable to obtain or refusal of informed consent from patient
Conditions Pulmonary Hypertension, Systemic Scleros...
Phase Not Applicable
Enrollment 450
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure \>=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.

Design

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

Interventions / Regimen

  • Other: No intervention. Biospecimen collection only — Biospecimen collection

Primary Outcomes

  • Collection of biospecimens (10 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: 2017-12-29
Completion: 2027-10
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 450 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans
Contact Information
Study Contact:
Matthew R Lammi, MD, MSCR
5045684634
mlammi@lsuhsc.edu
Matthew Lammi, MD, MSCR
504-568-4634
mlammi@lsuhsc.edu
University Medical Center-New Orleans
Interventions
  • Other: No intervention. Biospecimen collection only — Biospecimen collection
Study Locations (1 sites)
University Medical Center-New Orleans, New Orleans, Louisiana 70112 United States
Eligibility Criteria
Inclusion Criteria: * Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR * Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR * Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR * Undergoing outpatient right heart catheterization Exclusion Criteria: * Age\<18 * Pregnant * Unable to understand English * Currently incarcerated * Unwilling or unable to sign informed consent
Conditions Hypertension, Left Ventricular Hypertrop...
Phase Not Applicable
Enrollment 125
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.

Design

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

Primary Outcomes

  • Baseline Urine Angiotensin-(1-7)/Creatinine Ratio (Baseline)
  • Change in Urine Angiotensin-(1-7)/Creatinine Ratio (Baseline through 2 years)
  • Baseline Urine Angiotensin II/Angiotensin-(1-7) Ratio (Baseline)
  • Change in Urine Angiotensin II/Angiotensin-(1-7) Ratio (Baseline through 2 years)
  • Baseline Plasma Angiotensin-(1-7) Level (Baseline)
  • Change in Plasma Angiotensin-(1-7) Level (Baseline through 2 years)
  • Baseline Plasma Angiotensin II/Angiotensin-(1-7) Ratio (Baseline)
  • Change in Plasma Angiotensin II/Angiotensin-(1-7) Ratio (Baseline through 2 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: 2021-05-19
Completion: 2026-12
Eligibility
Age: 7 Years – 18 Years
Sex: ALL
Volunteers: true
Enrollment: 125 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wake Forest University Health Sciences
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Andrew M South, MD, MS (PRINCIPAL_INVESTIGATOR) - Wake Forest Health Sciences
Contact Information
Study Contact:
Andrew M South, MD, MS
336.716.9640
asouth@wakehealth.edu
Caroline B Lucas
336.713.8038
cblucas@wakehealth.edu
Andrew M South, MD, MS
336-716-9640
asouth@wakehealth.edu
Wake Forest Health Sciences
Interventions
N/A
Study Locations (1 sites)
Wake Forest Health Sciences, Winston-Salem, North Carolina 27157 United States
Eligibility Criteria
INCLUSION CRITERIA: HYPERTENSION COHORT * 7-18 years of age at time of enrollment * Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic * Age \<13 years: BP ≥95th %ile or ≥130/80 mmHg (whichever is lower) * Age ≥13 years: BP ≥130/80 mmHg * Participants and their caregivers must be willing and able to commit to completing the study assessments EXCLUSION CRITERIA: HYPERTENSION COHORT * \<7 years or \>18 years of age at time of enrollment * BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days; * Age \<13 years: BP \<95th %ile or \<130/80 mmHg (whichever is lower) * Age ≥13 years: BP \<130/80 mmHg * A confirmed secondary cause of hypertension * Confounding medical condition (heart or kidney disease \[except hypertension-associated heart changes on echocardiogram or albuminuria\], vascular/inflammatory disease, or diabetes) * Inability to complete study assessments * Non-English/Spanish speakers * Current pregnancy * Ward of the State INCLUSION CRITERIA: CONTROL COHORT * 7-18 years of age at time of enrollment * Normal BP based on ≥3 prior office BP measurements on separate days; * Age \<13 years: BP \<90th %ile or \<120/80 mmHg (whichever is lower) * Age ≥13 years: BP \<120/80 mmHg * Participants and their caregivers must be willing and able to commit to completing the study assessments EXCLUSION CRITERIA: CONTROL COHORT * \<7 or \>18 years of age at time of enrollment * Elevated BP or hypertension, based on ≥3 prior office BP measurements on separate days: * Age \<13 years: BP ≥90th %ile or ≥120/80 mmHg (whichever is lower) * Age ≥13 years: BP ≥120/80 mmHg * History of elevated BP or hypertension * Current use of BP-lowering medications * Confounding medical condition (heart or kidney disease, vascular/inflammatory disease, or diabetes) * Inability to complete study assessments * Non-English/Spanish speakers * Current pregnancy * Ward of the State
Conditions Preeclampsia (PE), Hypertensive Disorder...
Phase Not Applicable
Enrollment 385
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before. This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Design

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

Interventions / Regimen

  • Diagnostic Test: Hyperspectral imaging — Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital.
  • Diagnostic Test: Further markers of endothelial dysfunction — At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery.

Primary Outcomes

  • Time Until Delivery (observation period until 6 months after delivery)
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: 2025-05-08
Completion: 2027-07
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: true
Enrollment: 385 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heidelberg University
Principal Investigators:
  • Dr. med. Alexandra von Au (PRINCIPAL_INVESTIGATOR) - University Heidelberg
Contact Information
Study Contact:
Dr. med. Anna Scholz
+49 6221 56 32080
anna.scholz@med.uni-heidelberg.de
Dr. med. Anna Scholz
+49 6221 56 32080
anna.scholz@med.uni-heidelberg.de
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Alexandra von Au, Dr. med.
alexandra.vonau@med.uni-heidelberg.de
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Interventions
  • Diagnostic Test: Hyperspectral imaging — Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital.
  • Diagnostic Test: Further markers of endothelial dysfunction — At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery.
Study Locations (1 sites)
Heidelberg University Hospital, Department of Gynecology and Obstetrics, Heidelberg, 69120 Germany
Eligibility Criteria
Inclusion Criteria: * singleton pregnancies * Age ≥ 18 years * Patient's ability to provide consent * written informed consent Exclusion Criteria: * Lack of consent * Language barrier * Dark to very dark skin type * Severe fetal chromosomal/genetic/structural anomalies * Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)
Conditions Hepatocellular Carcinoma (HCC), Esophage...
Phase PHASE4
Enrollment 120
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-13
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to evaluate whether endoscopic variceal ligation (EVL) or carvedilol is more effective at preventing the first esophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC). It will also learn about the safety of EVL and carvedilol in patients with HCC. The main questions it aims to answer are: Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs. What medical problems do participants have when undergoing EVL or taking carvedilol? Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC. Participants will: Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol, or Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.

Design

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

Interventions / Regimen

  • Procedure: Endoscopic variceal ligation — EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically.
  • Drug: Carvedilol — The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \&lt; 90 mmHg), bradycardia (resting heart rate \&lt; 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.

Primary Outcomes

  • Esophageal variceal bleeding (3 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-10-01
Completion: 2030-10
Eligibility
Age: 20 Years – 90 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Taipei Veterans General Hospital, Taiwan
Contact Information
Study Contact:
Tsung-Chieh Yang, MD
+886-2-28712121
tcyang@vghtpe.gov.tw
Ming-Chih Hou, MD
+886-2-28712121
mchou@vghtpe.gov.tw
Tsung-Chieh Yang, MD
+886-2-28712121
tcyang@vghtpe.gov.tw
Taipei Veterans General Hospital
Interventions
  • Procedure: Endoscopic variceal ligation — EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically.
  • Drug: Carvedilol — The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \&lt; 90 mmHg), bradycardia (resting heart rate \&lt; 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.
Study Locations (1 sites)
Taipei Veterans General Hospital, Taipei, 11217 Taiwan
Eligibility Criteria
Inclusion Criteria: \- Patients with HCC and high-risk EVs, confirmed through imaging and clinical data (classified as F2 or F3 EVs according to Beppu et al. classification) Exclusion Criteria: * Age less than 20 years or greater than 90 years. * History of esophageal variceal bleeding. * Previous treatment for EVs, including EVL, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt (TIPS), or surgical interventions. * Use of non-selective β-blockers within two weeks prior to enrollment. * Contraindications for non-selective β-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, poorly controlled diabetes, and severe peripheral artery disease. * Presence of other end-stage organ diseases, including terminal cancers other than HCC, heart failure, and renal failure. * Pregnant women.