Phenotypic Classification of FMR With CMR

Recruiting now

Conditions studied: Nonischemic Congestive Cardiomyopathy, Functional Mitral Regurgitation, Ischemic Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT05965258

Run by

The Cleveland Clinic

People needed

360

Starts

2023-08-29

Expected to finish

2028-12-31

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• >moderate aortic regurgitation/stenosis,
• <18 years of age,
• acute myocarditis,
• eGFR<15
• HCM
• cardiac amyloidosis/sarcoidosis
• prior mitral valve intervention
• myocardial infarction within 8 weeks of CMR

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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