Carvedilol versus metoprolol succinate in people with heart failure and an implanted defibrillator
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
This study will test whether switching from metoprolol succinate to carvedilol reduces ICD therapies, heart-related hospitalizations, or cardiovascular death in adults with HFrEF and an ICD.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 13 sites (Scottsdale, Arizona and 12 other locations) |
| Trial ID | NCT06964464 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, open-label randomized trial will enroll 2,000 adults with heart failure with reduced ejection fraction (HFrEF) who have an implantable cardioverter defibrillator, with an initial 18-month feasibility phase of 100 participants at 15 sites. Eligible participants currently on metoprolol succinate will be randomized 1:1 to continue metoprolol succinate or switch to an equivalent dose of carvedilol, with dose titration as tolerated. Participants will be followed for up to three years with regular ICD interrogations, medication adherence monitoring, healthcare utilization tracking, and quality-of-life surveys. The primary outcome is a composite of first ICD therapy (appropriate or inappropriate), cardiovascular hospitalization, or cardiovascular death, and secondary outcomes include ICD shock burden and patient-reported outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with HFrEF (LVEF <50%), an ICD implanted for primary prevention, currently treated with metoprolol succinate, and willing to switch to carvedilol are ideal candidates.
Not a fit: Patients who are intolerant or contraindicated to carvedilol, have systolic blood pressure <100 mmHg, are on other beta-blockers, or do not have an ICD for primary prevention are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, switching to carvedilol could lower ICD therapies and cardiovascular hospitalizations and improve survival and quality of life for patients with HFrEF and an ICD.
How similar studies have performed: Prior trials such as COMET showed carvedilol had advantages over metoprolol tartrate, but randomized evidence directly comparing carvedilol with metoprolol succinate in ICD patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability * Current treatment with metoprolol succinate and willing to switch to carvedilol * LVEF \<50% during the past 12 months prior to consent Exclusion Criteria: * Unwilling or unable to follow the protocol * Treatment with any other ßB than metoprolol succinate or no ßB treatment * Known prior intolerance or contraindication to carvedilol * Systolic blood pressure \<100 mmHg * Enrollment in another clinical trial * Inability or unwilling to consent
Where this trial is running
Scottsdale, Arizona and 12 other locations
- HonorHealth — Scottsdale, Arizona, United States (Recruiting)
- AdventHealth Redmond — Rome, Georgia, United States (Recruiting)
- AdventHealth Shawnee Mission — Shawnee Mission, Kansas, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- University of Mossouri — Columbia, Missouri, United States (Recruiting)
- Creighton University Medical Center — Omaha, Nebraska, United States (Recruiting)
- Suny Downstate — Brooklyn, New York, United States (Recruiting)
- New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- CHRISTUS Trinity Mother Frances Health System — Tyler, Texas, United States (Recruiting)
- Health University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Mehmet Aktas, M.D.
- Email: Mehmet_Aktas@URMC.Rochester.edu
- Phone: 585-275-5391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.