Phenotypic Classification of FMR With CMR
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:
🦠 Nonischemic Congestive Cardiomyopathy 🦠 Functional Mitral Regurgitation
🗓️ Study Start (Actual) 29 August 2023
🗓️ Primary Completion (Estimated) 31 December 2028
✅ Study Completion (Estimated) 31 December 2028
👥 Enrollment (Estimated) 360
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1 CMR LVEF \<50% 2.FMR Fraction\>20%, with adequate image quality and no evidence of severe obstructive CAD

    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
    • 9. ischemic infarct pattern on CMR
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 July 2023
  • First Submitted that Met QC Criteria 20 July 2023
  • First Posted 28 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 October 2023
  • Last Update Posted 27 October 2023
  • Last Verified October 2023