NCT07539298

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
44mo left

Started May 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Atrial Functional Mitral Regurgitation

Keywords

mitral regurgitationAtrial functional mitral regurgitationvalsartanplacebomitral valve leafletsrandomized, double-blind, placebo-controlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Mitral leaflet size

    Mitral leaflet size by 3D echo and its variation vs baseline.

    Baseline VS 12 months

Secondary Outcomes (5)

  • MR progression

    MR grade at 12 months follow-up vs baseline

  • Left ventricular volume and function

    baseline VS 12 months follow-up

  • Pulmonary artery pressure

    baseline VS 12 months follow-up

  • Left atrial volume

    Baseline VS 12 months follow-up

  • Mitral thickness

    Baseline VS 12 months follow-up

Study Arms (2)

Valsartan

EXPERIMENTAL

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

Drug: Valsartan

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Drug: Placebo

Interventions

ValsartanDRUG

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

Valsartan
PlaceboDRUG

Placebo that looks like valsartan (caps)

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Central Study Contacts

Jonathan Beaudoin

CONTACT

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

Maude Jolicoeur

CONTACT

1 (418) 656-8711

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04