Actively Recruiting
Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation
Led by The Cleveland Clinic · Updated on 2025-10-20
360
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating functional mitral regurgitation (FMR) in patients with non-ischemic and ischemic cardiomyopathy to develop personalized risk predictions using advanced cardiac magnetic resonance (CMR) imaging. The study aims to identify CMR biomarkers that predict heart recovery after modern treatments for FMR. This research addresses the challenges of defining FMR severity and choosing the best treatment approach, with the goal of improving patient outcomes through better selection criteria. The study plans to enroll 360 adults over 18 years old with reduced heart function and significant FMR who are referred for CMR evaluation. Participants will receive optimized guideline-directed medical therapy for heart failure and have follow-up CMR scans at 6 months. Those with persistent or worsening FMR may be referred for MitraClip treatment, followed by additional CMR scans 6 months after the procedure. The study includes comparison groups of patients receiving different treatments and uses a dedicated cardiac MRI scanner for imaging. Participants will be closely monitored with regular clinic visits every two weeks until medical therapy is optimized. Researchers will assess changes in heart function, FMR severity, blood markers, exercise capacity, hospitalizations, arrhythmias, and other cardiovascular events over follow-up periods up to 36 months. The main outcome is a combined measure of heart-related death, heart transplant, or mechanical heart support. This detailed evaluation will help identify imaging predictors and improve treatment strategies for FMR patients.
CONDITIONS
Brief Title
Phenotypic Classification of FMR With CMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CMR left ventricular ejection fraction less than 55%
- Functional mitral regurgitation fraction greater than 20% or echocardiographic criteria indicating at least moderate mitral regurgitation with good image quality
- Adults aged 18 years or older
You will not qualify if you...
- Moderate or greater aortic 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 magnetic resonance imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants referred for optimization of guideline-directed medical therapy (mGDMT) are followed every 2 weeks until therapy is optimized.
Biweekly visits until optimized
Duration - Baseline and 6 months follow-up
Participants undergo baseline and follow-up cardiac magnetic resonance (CMR) imaging to evaluate heart function and mitral regurgitation severity.
2 visits (in-person) for CMR imaging
Duration - 6 months post-MitraClip treatment
For participants referred to MitraClip treatment after medical optimization, additional follow-up CMR imaging is performed 6 months post-procedure to assess treatment response.
1 visit (in-person) for follow-up CMR
Duration - Additional 6 months post-second MitraClip treatment
Participants who undergo MitraClip treatment after persistent or progressive mitral regurgitation at 6 months have a second follow-up CMR 6 months after the procedure.
1 visit (in-person) for second follow-up CMR
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
Deborah Kwon, MD
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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