NCT05965258 Phenotypic Classification of FMR With CMR
| NCT ID | NCT05965258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Nonischemic Congestive Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-08-29 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2023-08-29 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Deborah Kwon, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05965258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nonischemic Congestive Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05965258 currently recruiting?
Yes, NCT05965258 is actively recruiting participants. Contact the research team at kwond@ccf.org for enrollment information.
Where is the NCT05965258 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05965258 clinical trial?
NCT05965258 is sponsored by The Cleveland Clinic. The principal investigator is Deborah Kwon, MD at The Cleveland Clinic. The trial plans to enroll 360 participants.