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Optimize mGDMT for Mitral Regurgitation

N/A
Recruiting
Led By Deborah Kwon, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1 CMR LVEF \<50% 2.FMR Fraction\>20%, with adequate image quality and no evidence of severe obstructive CAD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Eligible Conditions
  • Congestive Cardiomyopathy
  • Mitral Regurgitation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of cardiac mortality, heart transplant, or LVAD implantation.
Secondary outcome measures
Arrhythmias
Change in 6-minute walk test
Change in FMR
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Optimize mGDMTExperimental Treatment1 Intervention
NICM patients referred for mGDMT optimization
Group II: MitraClip and mGDMTExperimental Treatment1 Intervention
NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,151 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,315 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,833,847 Total Patients Enrolled
~240 spots leftby Dec 2028