Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT05965258

Conditions

Nonischemic Congestive Cardiomyopathy

Functional Mitral Regurgitation

Ischemic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac magnetic resonance (CMR)

Study Details

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

Study ID

NCT05965258

Start date

Aug 29, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Optimize mGDMT

NICM patients referred for mGDMT optimization

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

Interventions

Cardiac magnetic resonance (CMR)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-10-20.