NCT07539298 Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot
| NCT ID | NCT07539298 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Jonathan Beaudoin |
| Condition | Atrial Functional Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-07-13 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07539298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Functional Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07539298 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07539298 currently recruiting?
Yes, NCT07539298 is actively recruiting participants. Contact the research team at jonathan.beaudoin@criucpq.ulaval.ca for enrollment information.
Where is the NCT07539298 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT07539298 clinical trial?
NCT07539298 is sponsored by Jonathan Beaudoin. The trial plans to enroll 50 participants.