Phenotypic Classification of FMR With CMR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac magnetic resonance (CMR)

    Diagnostic test

    Cardiac magnetic resonance (CMR) at 6 months. If referred to MitraClip, CMR will be performed at 6 months from the procedure.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Optimize mGDMT1 intervention
Group B: MitraClip and mGDMT1 intervention

Trial outcomes

Primary outcomes

1

Composite of cardiac mortality, heart transplant, or LVAD implantation.

Occurrence of cardiac mortality and/or heart transplant and/or LVAD implantation

Time frame
Up to 36 months

Secondary outcomes

1

Change in FMR

a change of \>5 units/percentage points compared to baseline

Time frame
6 months
2

Change in NT-proBNP

30% change in NT-proBNP or decrease to level \< 1000 compared to baseline

Time frame
6 months
3

Change in KCQL score

5 point change in KCQL score compared to baseline

Time frame
6 months
4

Change in 6-minute walk test

25 meter change in 6-minute walk test compared to baseline

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator