360 Participants Needed

Phenotypic Classification of FMR With CMR

DK
Overseen ByDeborah Kwon, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Research Team

DK

Deborah Kwon, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

Your cardiac MRI left ventricular ejection fraction is less than 50%, your myocardial fractional motion rate is greater than 20%, with adequate imaging quality and no signs of severe obstructive coronary artery disease.

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Optimize mGDMTExperimental Treatment1 Intervention
NICM patients referred for mGDMT optimization
Group II: MitraClip and mGDMTExperimental Treatment1 Intervention
NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+