Recruiting
Phase 2
Phase 3

Valsartan

Sponsor:

Jonathan Beaudoin

Code:

NCT07539298

Conditions

Atrial Functional Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Valsartan

Placebo

Study Details

Brief 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

Conditions

Atrial Functional Mitral Regurgitation

Study ID

NCT07539298

Start date

Jul 13, 2026

Status verified date

Aug, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Valsartan

Valsartan 40 mg/tablet twice daily vs placebo. Titration up to 160 mg twice daily based on tolerance, blood pressure and renal function.

Placebo

Placebo that looks like valsartan (caps)

Primary outcome measure

  • Mitral leaflet size [ Time Frame: Baseline VS 12 months ]

Central Contacts and Locations

Central contacts

Jonathan Beaudoin

1 (418) 656-8711jonathan.beaudoin@criucpq.ulaval.ca

Maude Jolicoeur

1 (418) 656-8711

Locations

Institut universitaire de cardiologie et de pneumologie de Québec-ULaval

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

Jonathan Beaudoin, MD

418-656-8711jonathan.beaudoin@criucpq.ulaval.ca

Maude Jolicoeur, M.Sc

418-656-8711maude.jolicoeur@criupcq.ulaval.ca

More Information

Sponsor

Jonathan Beaudoin

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • mitral regurgitation
  • Atrial functional mitral regurgitation
  • valsartan
  • placebo
  • mitral valve leaflets
  • randomized, double-blind, placebo-controlled clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jonathan Beaudoin on 2026-08-20.