Personalized risk prediction for functional mitral regurgitation using cardiac imaging
Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation
The Cleveland Clinic · NCT05965258
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 type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05965258 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in using cardiac magnetic resonance imaging for similar conditions, indicating a promising approach for this research.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nonischemic Congestive Cardiomyopathy, Functional Mitral Regurgitation, Ischemic Cardiomyopathy