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

A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06150560

Acronym

VALUE

Enrollment

120

Registered

2023-11-29

Start date

2024-04-01

Completion date

2028-06-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coarctation of Aorta, High Blood Pressure

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.

Interventions

DRUGLosartan

50mg administered orally once daily for 52 weeks.

DRUGAmlodipine

5mg Amlodipine administered orally once daily for 52 weeks.

DRUGPlacebo

Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Contacts

CONTACTACHD Research Program

RSTACHDRESPRG@mayo.edu(507) 293-2565

CONTACTAlexander Egbe, MBBS, MPH

Egbe.Alexander@mayo.edu(507) 284-2520

PRINCIPAL_INVESTIGATORAlexander Egbe, MBBS, MPH

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026