Actively Recruiting
Phenotypic Classification of FMR With CMR
Led by The Cleveland Clinic · Updated on 2025-10-20
360
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phenotypic Classification of FMR With CMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cardiac MRI showing left ventricular ejection fraction less than 55%
- Functional mitral regurgitation fraction greater than 20% or echocardiographic evidence of at least moderate mitral regurgitation with good image quality
You will not qualify if you...
- More than moderate aortic valve regurgitation or stenosis
- Under 18 years of age
- Acute myocarditis
- Estimated glomerular filtration rate less than 15
- Hypertrophic cardiomyopathy
- Cardiac amyloidosis or sarcoidosis
- Prior mitral valve intervention
- Myocardial infarction within 8 weeks before cardiac MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
Deborah Kwon, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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