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

What this Trial Is About

Researchers are evaluating the effects and mechanism of action of Losartan, an angiotensin-II receptor blocker, in treating patients with repaired coarctation of the aorta who also have high blood pressure. This Phase III trial aims to compare Losartan with Amlodipine and a placebo to better understand cardiovascular remodeling in this population. Participants with coarctation of the aorta and high blood pressure will be randomly assigned to one of three groups: Losartan, Amlodipine, or placebo. Losartan is given as a 50mg oral dose once daily, Amlodipine as 5mg once daily, and the placebo group receives capsules without active ingredients, all for a duration of 52 weeks. The study is double-blind, ensuring neither participants nor researchers know the assigned treatments during the trial. During the 52-week period, participants will undergo assessments including measuring changes in left ventricular fibrosis and exercise capacity. These evaluations occur at the start and end of the treatment period to monitor cardiovascular remodeling and physical fitness. The trial is designed to carefully monitor participants' health and responses to the treatments while aiming to advance understanding of managing repaired coarctation of the aorta with hypertension.

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