Cardiac MRI for Mitral Regurgitation

Overseen By Deborah Kwon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Aortic regurgitation, Myocarditis, HCM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors predict risks for individuals with functional mitral regurgitation (FMR), a heart condition where the mitral valve doesn’t close tightly, allowing blood to flow backward. Researchers use advanced heart imaging to identify patients who might benefit from specific treatments. The study examines two treatment approaches: optimizing medical therapy and using a device called MitraClip, a minimally invasive procedure to repair the mitral valve. Adults with noticeable heart valve issues and reduced heart function might be suitable candidates for the trial. Participants will undergo heart scans and follow-up checks to assess treatment effectiveness.

As a Phase 2 trial, this research focuses on measuring treatment efficacy in an initial, smaller group, offering participants a chance to benefit from potentially effective treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It mentions that patients will be referred for optimization of medical therapy, which might involve changes to your current treatment plan.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the MitraClip treatment is safe for patients with severe mitral regurgitation, a heart valve problem. Studies have found that it reduces hospital visits for heart failure and lowers the risk of death from any cause. Additionally, recipients of this treatment often experience an improved quality of life over time.

The MitraClip has been successfully used for both primary and secondary mitral regurgitation in patients with heart failure, demonstrating consistent safety across various situations.

The other treatment option, optimized medical therapy (mGDMT), is a standard method for managing heart conditions. It involves adjusting medications to optimal levels for each patient. This approach is generally well-tolerated and aims to improve heart function and symptoms.

Overall, both treatments in the study have a strong safety record. Extensive research supports the safe use of the MitraClip in people with heart valve issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to refine the treatment strategy for patients with NICM (non-ischemic cardiomyopathy) and functional mitral regurgitation (FMR) using advanced imaging techniques. Unlike standard treatment options that rely on generalized approaches, this study leverages cardiac magnetic resonance (CMR) imaging to classify patients and optimize management with MitraClip and maximized guideline-directed medical therapy (mGDMT). By understanding the phenotypic characteristics of FMR better, this trial could lead to personalized treatment plans that enhance outcomes and tailor interventions more precisely to individual patient needs.

What evidence suggests that this trial's treatments could be effective for functional mitral regurgitation?

Research shows that the MitraClip, a device used to repair the mitral valve in the heart, can greatly benefit patients with functional mitral regurgitation (FMR). In this trial, one group of participants will receive the MitraClip along with optimized medical therapy (mGDMT). Previous studies have shown that patients who received the MitraClip with standard heart failure treatment had a 35.8% chance of hospitalization for heart failure within 24 months, significantly lower than the 67.9% chance for those who only received standard treatment. Another study found that over five years, 73.6% of patients with the MitraClip experienced death or hospitalization for heart failure, compared to 91.5% in those without the device. Additionally, after one year, patients treated with the MitraClip showed a clear improvement in their heart valve condition. These findings suggest that the MitraClip can help reduce hospital visits and improve heart health in patients with FMR. ^{2 3 6 7 8}

Who Is on the Research Team?

Deborah Kwon, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Your cardiac MRI left ventricular ejection fraction is less than 50%, your myocardial fractional motion rate is greater than 20%, with adequate imaging quality and no signs of severe obstructive coronary artery disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization of mGDMT

Participants are referred for optimization of medical therapy with Heart Failure Pharmacist Clinic and followed every 2 weeks until optimized

Variable, until optimized

Bi-weekly visits

Follow-up CMR

Participants undergo follow-up CMR studies at 6 months to assess FMR and cardiac function

6 months

1 visit (in-person)

MitraClip Intervention

NICM patients with significant FMR undergo MitraClip treatment followed by a follow-up CMR 6 months post-intervention

6 months post-intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mortality, arrhythmias, and other cardiac events

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Phenotypic Classification of FMR With CMR

How Is the Trial Designed?

Group I: Optimize mGDMT Experimental Treatment 1 Intervention

NICM patients referred for mGDMT optimization

Group II: MitraClip and mGDMT Experimental Treatment 1 Intervention

NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. jacc.org jacc.org/doi/10.1016/S0735-1097%2820%2931805-2

OUTCOMES OF TRANSCATHETER MITRAL VALVE ... In all pts, there was no significant difference in the 2-year rate of death or HF hospitalization (HFH) in pts with ICM vs NICM (42.8% vs 39.2%, ...

2. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2018/09/21/20/12/COAPT

Cardiovascular Outcomes Assessment of the MitraClip ... The primary effectiveness endpoint, HF hospitalization at 24 months for MitraClip + GDMT vs. GDMT, was 35.8% vs. 67.9% (hazard ratio [HR] 0.53, ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300213

Five-Year Follow-up after Transcatheter Repair ... Death or hospitalization for heart failure within 5 years occurred in 73.6% of the patients in the device group and in 91.5% of those in the control group ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4598489/

MitraClip—data analysis of contemporary literature - PMC MC patients showed a 1-year mortality of 13%. Long-term data were not available for MVS and thus results were not comparable. By contrast, patients under best ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.117.031733?doi=10.1161/CIRCULATIONAHA.117.031733

One-Year Outcomes After MitraClip for Functional Mitral ... Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients (P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10053175/

Safety and efficacy of MitraClip in acutely ill (NYHA Class ... MitraClip in patients with severe MR and NYHA Class IV was found to be safe and effective in treating MR, and significantly improving QoL and long‐term ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2474870622004845

MitraClip Treatment of Secondary Mitral Regurgitation in ... The MitraClip system has evolved as a new tool for the treatment of secondary mitral regurgitation (SMR) in patients with heart failure and reduced left ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01626079

Study Details | NCT01626079 | Cardiovascular Outcomes ... The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in ...