50 Participants NeededMy employer runs this trial

Valsartan for Mitral Regurgitation

(VALORIA-Pilot Trial)

JB
MJ
Overseen ByMaude Jolicoeur
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Jonathan Beaudoin
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

This trial is for adults with a leaky mitral heart valve (mitral regurgitation) caused by changes in the atrium, not valve damage. Participants must have an enlarged left atrium, normal heart pumping function, and at least moderate leakage.

Inclusion Criteria

3. Normal (≥ 50%) left ventricular ejection fraction
4. At least moderate MR grade by multiparametric assessment.
I do not have any disease affecting my mitral heart valve.
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What Are the Treatments Tested in This Trial?

Interventions

  • Valsartan

Trial Overview

The study compares valsartan (a blood pressure medicine) to a placebo to see if it can slow down worsening of mitral regurgitation over 12 months. Participants are randomly assigned to take either valsartan or placebo twice daily.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ValsartanExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonathan Beaudoin

Lead Sponsor

Fondation IUCPQ

Collaborator

Trials
4
Recruited
290+

Laval University

Collaborator

Trials
439
Recruited
178,000+