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Phenotypic Classification of FMR With CMR

Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1 CMR LVEF \<55% 2.FMR Fraction\>20% or echo criteria consistent with at least moderate mitral regurgitation with adequate image quality

Exclusion Criteria:

1. \>moderate aortic regurgitation/stenosis,
2. \<18 years of age,
3. acute myocarditis,
4. eGFR\<15
5. HCM
6. cardiac amyloidosis/sarcoidosis
7. prior mitral valve intervention
8. myocardial infarction within 8 weeks of CMR

About the study

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.

What is being tested

• Cardiac magnetic resonance (CMR) (diagnostic test)

Sponsor: The Cleveland Clinic · Participants: 360 · Started: Aug 29, 2023

Contact the study team

• Deborah Kwon, MD · Phone: 216-444-8526

Official record on ClinicalTrials.gov — NCT05965258

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.