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NCT Number: NCT06150560

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

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

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Key information

Conditions

Coarctation of Aorta Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases High Blood Pressure Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

50mg administered orally once daily for 52 weeks.

Other names: Cozaar

Amlodipine

Drug

5mg Amlodipine administered orally once daily for 52 weeks.

Placebo

Drug

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

Primary outcomes

  1. Change in Left Ventricular (LV) Fibrosis

    Time frame: 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 outcomes

  1. Change in Exercise Capacity (peak VO2)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

ACHD Research Program

CONTACT

[email protected]

(507) 293-2565

Alexander Egbe, MBBS, MPH

CONTACT

[email protected]

(507) 284-2520

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: VALUE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 29, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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