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Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Sponsor: University of Rochester
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2025-08-17
Completion Date
2031-07-01
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Metoprolol Succinate
Metoprolol succinate is a beta-blocker used for the management of heart failure with reduced ejection fraction (HFrEF). In this study, participants in the metoprolol succinate group will remain on their current treatment regimen with metoprolol succinate. The dose will be titrated to the recommended target dose as per the study protocol. The intervention aims to evaluate the effectiveness of continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
Carvedilol
Carvedilol is a non-selective beta-blocker with alpha-blocking activity used in the treatment of heart failure. In this study, participants assigned to the carvedilol group will switch from metoprolol succinate to carvedilol at an equivalent dose. The carvedilol dose will be titrated to recommended target doses according to the study protocol. This intervention aims to compare the effectiveness of carvedilol versus metoprolol succinate in improving clinical outcomes in patients with heart failure and ICDs.
Locations (13)
HonorHealth
Scottsdale, Arizona, United States
AdventHealth Redmond
Rome, Georgia, United States
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mossouri
Columbia, Missouri, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Suny Downstate
Brooklyn, New York, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States
Health University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States