RecruitingPhase 3NCT06150560

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


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called the VALUE Trial) is studying whether a blood pressure medication called an angiotensin-II receptor blocker (ARB) can prevent or reverse cardiovascular changes in people who have had surgical repair of a narrowing of the aorta (called coarctation of the aorta, or COA). People who have had this repair often develop high blood pressure and heart changes later in life, and researchers want to see if ARBs can help. **You may be eligible if...** - You are 18 years or older - You have previously had surgical repair of coarctation of the aorta (COA) - You have mild to moderate high blood pressure (systolic blood pressure averaging 100–139 mmHg in the office) **You may NOT be eligible if...** - You are currently taking a beta-blocker medication - You are pregnant or breastfeeding - Your kidneys are not working well (eGFR below 30) - You have high potassium levels in your blood - You have severe aortic or mitral valve disease - You have a confirmed diagnosis of coronary artery disease - You have taken blood pressure medication in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06150560


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