Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
HonorHealth
RECRUITING
Scottsdale
Georgia
AdventHealth Redmond
RECRUITING
Rome
Kansas
AdventHealth Shawnee Mission
RECRUITING
Shawnee Mission
Michigan
Henry Ford Health System
RECRUITING
Detroit
Missouri
University of Mossouri
RECRUITING
Columbia
Nebraska
Creighton University Medical Center
RECRUITING
Omaha
New York
New York-Presbyterian Brooklyn Methodist Hospital
RECRUITING
Brooklyn
Suny Downstate
RECRUITING
Brooklyn
University of Rochester Medical Center
RECRUITING
Rochester
Texas
CHRISTUS Trinity Mother Frances Health System
RECRUITING
Tyler
Utah
Health University of Utah
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Wisconsin
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Contact Information
Primary
Mehmet Aktas, M.D.
Mehmet_Aktas@URMC.Rochester.edu
585-275-5391
Backup
Nicole Guerrero, MBA
nicole.guerrero@heart.rochester.edu
0000000000
Time Frame
Start Date: 2025-08-17
Estimated Completion Date: 2031-07-01
Participants
Target number of participants: 2000
Treatments
Active_comparator: Metoprolol Succinate Group
Participants in this group will remain on their current treatment with metoprolol succinate. The dose of metoprolol succinate may be titrated to achieve recommended target doses as per the study protocol. The aim is to assess the outcomes associated with continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
Experimental: Carvedilol Group
Participants in this group will switch from metoprolol succinate to carvedilol at an equivalent dose. The dose of carvedilol will be titrated to the recommended target dose as per the study protocol. The goal is to evaluate the comparative effectiveness of carvedilol compared to metoprolol succinate in reducing cardiovascular events in patients with heart failure and an ICD.
Sponsors
Leads: University of Rochester
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov

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