Effects of VALsartan On atRIAl Mitral Regurgitation

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJonathan Beaudoin

About this trial

The goal of this clinical trial is to learn whether valsartan can slow the progression of atrial functional mitral regurgitation (AFMR) in adults with preserved left ventricular ejection fraction. The study will also evaluate the safety and tolerability of valsartan in this population.

The main questions it aims to answer are:

* Does treatment with valsartan reduce the progression of atrial functional mitral regurgitation compared with placebo? * Does valsartan have favorable effects on mitral valve leaflet remodeling and related cardiac structure and function? * Is valsartan safe and well tolerated in patients with atrial functional mitral regurgitation who do not currently require angiotensin-converting enzyme inhibitors or angiotensin receptor blockers?

Researchers will compare valsartan to a placebo (a look-alike substance with no active drug) to see if valsartan reduces the progression of atrial functional mitral regurgitation and improves clinical and imaging outcomes.

Participants will:

* Take valsartan or placebo twice daily for 12 months, with dose adjustments based on blood pressure, kidney function, and tolerance * Undergo 3D echocardiography at baseline, 6 months, and 12 months * Complete a 6-minute walk test at baseline and 12 months * Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 6 months, and 12 months * Undergo 24-hour ambulatory blood pressure monitoring at 1 month * Have regular safety monitoring, including phone follow-up at 7 days, blood tests at 1 month, and blood pressure checks after dose adjustments

Eligibility criteria

Qualifiers

No evidence of mitral organic disease

At least moderate left atrial dilatation (left atrial volume index ≥34 mL/m²)

Normal (≥ 50%) left ventricular ejection fraction and

At least moderate MR grade by multiparametric assessment.

Disqualifiers

Inability to provide informed consent

Indication for or ongoing treatment with ACEI/ARB

History of hypotension

Hypertension (>140/90 mmHg) *

Trial design

Treatments tested in this trial

  • Valsartan
  • Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Jonathan Beaudoin

Lead sponsor

Laval University

Sponsor institution

Fondation IUCPQ

Collaborator

Laval University

Collaborator