Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJonathan Beaudoin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inability to provide informed consent
Indication for or ongoing treatment with ACEI/ARB
History of hypotension
Hypertension (>140/90 mmHg) *
Trial design
Design model
Parallel
Treatments tested in this trial
Valsartan
DrugValsartan 40 mg/tablet twice daily vs placebo. Titration up to 160 mg twice daily based on tolerance, blood pressure and renal function.
Placebo
DrugPlacebo that looks like valsartan (caps)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ValsartanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mitral leaflet size
Mitral leaflet size (cm2) by 3D echo and its variation vs baseline.
Time frame
Baseline VS 12 monthsSecondary outcomes
1
MR progression
MR progression measured by imaging (3D echocardiography). Mitral regurgitation is graded on a scale of I-IV (grade I (mild MR), grade II (moderate MR), grade III (moderate-to-severe MR) and grade IV (severe MR)). A higher mitral regurgitation grade is generally associated with a worse outcome for the patient.
Time frame
MR grade at 12 months follow-up vs baseline2
Left ventricular volume
Left ventricular volume (mL) measured by imaging (3D echocardiography)
Time frame
baseline VS 12 months follow-up3
Left ventricular function
Left ventricular function (% ejection fraction) measured by imaging (3D echocardiography)
Time frame
baseline VS 12 months follow-up4
Pulmonary artery pressure
Pulmonary artery pressure measured by echocardiography (mmHg).
Time frame
baseline VS 12 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jonathan Beaudoin
Lead sponsor
Laval University
Sponsor institution
Fondation IUCPQ
Collaborator
Laval University
Collaborator
Source ClinicalTrials.gov