VALsartan on atRIAl Mitral Regurgitation Pilot Randomized Controlled Trial Phase 2
Summary
NIH ClinicalTrials.gov registered a Phase 2 pilot randomized controlled trial (NCT07539298) evaluating valsartan versus placebo for treatment of atrial functional mitral regurgitation in adults with preserved left ventricular ejection fraction. The 12-month study will assess progression reduction, mitral valve leaflet remodeling, and safety/tolerability. Participants will undergo 3D echocardiography, 6-minute walk tests, and Kansas City Cardiomyopathy Questionnaire assessments.
What changed
NIH registered a new Phase 2 clinical trial (NCT07539298) on ClinicalTrials.gov studying valsartan for atrial functional mitral regurgitation. The pilot randomized controlled trial will enroll adults with preserved left ventricular ejection fraction, comparing valsartan to placebo over 12 months with endpoints including mitral valve remodeling and clinical outcomes.
Pharmaceutical companies with valsartan products, healthcare providers treating AFMR patients, and clinical investigators may use this registry to identify trial sites, understand study design parameters, or consider patient referrals. The trial completion timeline and results may inform future regulatory submissions or label expansions for valsartan in this indication.
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Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effects of VALsartan On atRIAl Mitral Regurgitation: A Pilot Randomized Controlled Trial
Phase 2 NCT07539298 Kind: PHASE2 Apr 20, 2026
Abstract
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...
Conditions: Atrial Functional Mitral Regurgitation
Interventions: Valsartan, Placebo
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