A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

Phase 3

Recruiting

• Conditions: Coarctation of Aorta; High Blood Pressure
• Interventions: Drug: Placebo; Drug: Losartan; Drug: Amlodipine

• Registration Number: NCT06150560
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-29
• Study Start: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2028-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• B/S1 hypertension
• SBP 100-139 average based on 3 office measurements.
• Age 18 or Older
• Previous COA Repair

Exclusion Criteria

• Currently on beta blocker (BB) therapy
• Pregnancy/lactating
• eGFR<30
• Hyperkalemia (serum potassium >5.5mmol/L)
• Severe Aortic or Mitral valve stenosis or regurgitation
• Epicardial CAD diagnosis
• Received antihypertensive medications within the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.
Losartan Group	Losartan	Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
Amlodipine Group	Amlodipine	Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular (LV) Fibrosis	Baseline; Week 52	LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI).

Secondary Outcome Measures

Name	Time	Method
Change in Exercise Capacity (peak VO2)	Baseline; Week 52	Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), during supine bike cardiopulmonary exercise test (Stress Echocardiogram).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States