Phenotypic Classification of FMR With CMR

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05965258
Status
Recruiting
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Conditions

  • Functional Mitral Regurgitation
  • Ischemic Cardiomyopathy
  • Nonischemic Congestive Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cardiac magnetic resonance (CMR) — DIAGNOSTIC_TEST
    Cardiac magnetic resonance (CMR) at 6 months. If referred to MitraClip, CMR will be performed at 6 months from the procedure.

Study Details

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.

Key Dates

Start date
Aug 29, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
360 participants (estimated)

Arms

  • Arm: Optimize mGDMT
    NICM patients referred for mGDMT optimization
  • Arm: MitraClip and mGDMT
    NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment

Primary Outcome Measure

Composite of cardiac mortality, heart transplant, or LVAD implantation. [ Time Frame: Up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Deborah Kwon, MD
[email protected]
216-444-8526
Samir Kapadia, MD (SUB_INVESTIGATOR)
Wilson Tang, MD (SUB_INVESTIGATOR)
David Chen, PhD (SUB_INVESTIGATOR)
Xiaofeng Wang, PhD (SUB_INVESTIGATOR)
Marc Gillinov, MD (SUB_INVESTIGATOR)
Christopher Nguyen, PhD (SUB_INVESTIGATOR)
Nancy Obuchowski, PhD (SUB_INVESTIGATOR)

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