Phenotypic Classification of FMR With CMR

NCT05965258 | Recruiting

• 2 other identifiers: 23-7021R01HL170090-01
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonischemic Congestive Cardiomyopathy; Functional Mitral Regurgitation; Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Composite of cardiac mortality, heart transplant, or LVAD implantation.

  Occurrence of cardiac mortality and/or heart transplant and/or LVAD implantation

  Up to 36 months

Secondary Outcomes (11)

• Change in FMR

  6 months

• Change in NT-proBNP

  6 months

• Change in KCQL score

  6 months

• Change in 6-minute walk test

  6 months

• Recurrent heart failure hospitalization

  up to 1 year

Study Arms (2)

Optimize mGDMT

NICM patients referred for mGDMT optimization

Diagnostic Test: Cardiac magnetic resonance (CMR)

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

Diagnostic Test: Cardiac magnetic resonance (CMR)

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.

MitraClip and mGDMT; Optimize mGDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to Cleveland Clinic Structural Interventional Cardiology Clinic for evaluation of possible percutaneous MV intervention are routinely referred for CMR as part of their clinical protocol, and will be recruited for this prospective study. Additionally, patients clinically referred for CMR for evaluation of cardiomyopathy, who are found to have FMR RF \>20% for enrollment into this prospective study.

You may qualify if:

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

You may not qualify if:

• \>moderate aortic regurgitation/stenosis,
• \<18 years of age,
• acute myocarditis,
• eGFR\<15
• HCM
• cardiac amyloidosis/sarcoidosis
• prior mitral valve intervention
• myocardial infarction within 8 weeks of CMR

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Deborah Kwon, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Kwon, MD

CONTACT

216-444-8526; kwond@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 29, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)