Valsar­tan for Atrial Functional Mitral Regurgitation (AFMR) — Pilot

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial tests whether valsartan, an angiotensin receptor blocker, can slow the progression of AFMR compared with placebo in adults with preserved ejection fraction. The study also looks at changes in mitral valve leaflets and heart structure on imaging, as well as safety and tolerability in participants who are not already on ARB/ACE inhibitors. It combines phase 2 and phase 3 elements to assess both preliminary signals and more robust outcomes. Participants are randomized to valsartan or placebo and followed with clinical and imaging assessments. Eligibility requires moderate-to-severe atrial enlargement, preserved LV function, and MR without organic mitral disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. No evidence of mitral organic disease
2. At least moderate left atrial dilatation (left atrial volume index ≥34 mL/m²)
3. Normal (≥ 50%) left ventricular ejection fraction and
4. At least moderate MR grade by multiparametric assessment.

Exclusion Criteria:

1. Inability to provide informed consent
2. Indication for or ongoing treatment with ACEI/ARB
3. History of hypotension
4. Hypertension (\>140/90 mmHg) \*
5. Planned cardiac surgery (CABG or valve)
6. Ongoing or planned pregnancy
7. Chronic renal failure with eGFR \< 30 mL/min/1.73m2
8. Neurocognitive disorder
9. History of hyperkalemia
10. Medication interacting with valsartan

Where it's running

• Institut universitaire de cardiologie et de pneumologie de Québec-ULaval
  Québec, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Jonathan Beaudoin
• Email: jonathan.beaudoin@criucpq.ulaval.ca
• Phone: 1 (418) 656-8711

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Catheter ablation for people with persistent atrial fibrillation and severe atrial functional mitral regurgitation

  This will test whether adding catheter ablation to usual medicines helps adults with persistent atrial fibrillation and moderate-to-severe or severe atrial functional mitral regurgitation reduce valve leakage and improve symptoms and outcomes.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.