Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Recruiting now · Phase 4
Conditions studied: Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD), Beta-blocker Therapy, Cardiomyopathy
In brief
This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.
Key facts
- Study ID
- NCT06964464
- Run by
- University of Rochester
- People needed
- 2000
- Starts
- 2025-08-17
- Expected to finish
- 2031-07-01
- Last updated by the study team
- 2025-09-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- HonorHealth — Scottsdale, Arizona, United States (enrolling)
- AdventHealth Redmond — Rome, Georgia, United States (enrolling)
- AdventHealth Shawnee Mission — Shawnee Mission, Kansas, United States (enrolling)
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- University of Mossouri — Columbia, Missouri, United States (enrolling)
- Creighton University Medical Center — Omaha, Nebraska, United States (enrolling)
- Suny Downstate — Brooklyn, New York, United States (enrolling)
- New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- CHRISTUS Trinity Mother Frances Health System — Tyler, Texas, United States (enrolling)
- Health University of Utah — Salt Lake City, Utah, United States (enrolling)
- Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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