Comparing two beta-blocker heart medicines in people with heart failure and a defibrillator
Compares carvedilol with metoprolol succinate in adults with heart failure and an implanted defibrillator.
Plain-language title generated from the registry record
Registry title: Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Key facts
- Where
- Brooklyn, Columbia, Detroit, Madison, Omaha, Richmond, Rochester, Rome, Salt Lake City, Scottsdale, Shawnee Mission, and Tyler, United StatesSee the 13 sites
- Phase
- Phase 4
Where in United States
- New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, United StatesTaking people
- Suny DownstateBrooklyn, United StatesTaking people
- University of MossouriColumbia, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- University of Wisconsin Hospital and ClinicsMadison, United StatesTaking people
- Creighton University Medical CenterOmaha, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- AdventHealth RedmondRome, United StatesTaking people
- Health University of UtahSalt Lake City, United StatesTaking people
- HonorHealthScottsdale, United StatesTaking people
- AdventHealth Shawnee MissionShawnee Mission, United StatesTaking people
- CHRISTUS Trinity Mother Frances Health SystemTyler, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Rochester
- Trial code
- NCT06964464
- Record updated
- 18 September 2025
- Original description
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.Read full original descriptionShow less
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
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.
Inclusion: 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: Treatment with any other ßB than metoprolol succinate or no ßB treatment; Known prior intolerance or contraindication to carvedilol; Unwilling or unable to follow the protocol; Systolic blood pressure <100 mmHg; Enrollment in another clinical trial; Inability or unwilling to consent.