About this trial
The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR.
The prospective study entails aiming to recruit 360 adult patients (ages \>18 years) with EF 10-50% and FMR RF\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
>moderate aortic regurgitation/stenosis,
<18 years of age,
acute myocarditis,
eGFR<15
Trial population
Patients referred to Cleveland Clinic Structural Interventional Cardiology Clinic for evaluation of possible percutaneous MV intervention are routinely referred for CMR as part of their clinical protocol, and will be recruited for this prospective study. Additionally, patients clinically referred for CMR for evaluation of cardiomyopathy, who are found to have FMR RF \>20% for enrollment into this prospective study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cardiac magnetic resonance (CMR)
Diagnostic testCardiac magnetic resonance (CMR) at 6 months. If referred to MitraClip, CMR will be performed at 6 months from the procedure.
Treatment groups
Trial outcomes
Primary outcomes
Composite of cardiac mortality, heart transplant, or LVAD implantation.
Occurrence of cardiac mortality and/or heart transplant and/or LVAD implantation
Secondary outcomes
Change in FMR
a change of \>5 units/percentage points compared to baseline
Change in NT-proBNP
30% change in NT-proBNP or decrease to level \< 1000 compared to baseline
Change in KCQL score
5 point change in KCQL score compared to baseline
Change in 6-minute walk test
25 meter change in 6-minute walk test compared to baseline
Sponsors and contacts
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The Cleveland Clinic
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator