Actively Recruiting

Age: 18Years +
All Genders
NCT05965258

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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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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