Mitral Valve Regurgitation Clinical Trials

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Effects of VALsartan On atRIAl Mitral Regurgitation: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec-ULaval
RECRUITING
Québec
Contact Information
Primary
Jonathan Beaudoin
jonathan.beaudoin@criucpq.ulaval.ca
1 (418) 656-8711
Backup
Maude Jolicoeur
1 (418) 656-8711
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Valsartan
Valsartan 40 mg/tablet twice daily. . Titration up to 160 mg twice daily based on tolerance, blood pressure and renal function.
Placebo_comparator: Placebo
Placebo twice daily
Sponsors
Leads: Jonathan Beaudoin
Collaborators: Laval University, Fondation IUCPQ

This content was sourced from clinicaltrials.gov