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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Personalized risk prediction for functional mitral regurgitation using cardiac imaging

Official title: Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation

Run by The Cleveland Clinic · NCT05965258 · Data updated 2026-11-12

This study is testing if advanced heart imaging can help predict how well patients with functional mitral regurgitation will respond to treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment360 (estimated)
SponsorThe Cleveland Clinic
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedAugust 29, 2023
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedOctober 20, 2025
Trial IDNCT05965258 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with an ejection fraction of less than 55% and significant functional mitral regurgitation.

Probably not a fit

Patients with moderate to severe aortic regurgitation or stenosis, acute myocarditis, or those under 18 years of age may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to develop personalized risk prediction models for patients with functional mitral regurgitation (FMR) by utilizing advanced cardiac magnetic resonance (CMR) imaging biomarkers. The study will recruit 360 adult patients with reduced ejection fraction and significant FMR, who will undergo CMR evaluations and follow-up assessments after treatment optimization. By analyzing CMR data, the study seeks to identify predictors of reverse remodeling following modern therapies for FMR, ultimately improving patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to more accurate risk assessments and treatment strategies for patients with functional mitral regurgitation.

How similar studies have gone: Other studies have shown success in using cardiac magnetic resonance imaging for similar conditions, indicating a promising approach for this research.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

1. \>moderate aortic regurgitation/stenosis,
2. \<18 years of age,
3. acute myocarditis,
4. eGFR\<15
5. HCM
6. cardiac amyloidosis/sarcoidosis
7. prior mitral valve intervention
8. myocardial infarction within 8 weeks of CMR

Where it's running

  • Cleveland Clinic
    Cleveland, Ohio, United States     Recruiting

Study contacts

  • Principal investigator: Deborah Kwon, MD — The Cleveland Clinic
  • Study coordinator: Deborah Kwon, MD
  • Email: kwond@ccf.org
  • Phone: 216-444-8526

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Functional Mitral Regurgitation 6Ischemic Cardiomyopathy 24The Cleveland Clinic 127
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.