Recruiting

Carvedilol vs. Metoprolol

Sponsor:

University of Rochester

Code:

NCT06964464

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Sudden Cardiac Death

Ventricular Arrhythmia

Implantable Cardioverter Defibrillator (ICD)

Beta-blocker Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metoprolol Succinate

Carvedilol

Study Details

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Sudden Cardiac Death

Ventricular Arrhythmia

Implantable Cardioverter Defibrillator (ICD)

Beta-blocker Therapy

Study ID

NCT06964464

Start date

Aug 17, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Jun 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Composite Endpoint: First Occurrence of ICD Therapy, Cardiovascular Hospitalization, or Cardiovascular Death [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

AdventHealth Redmond

Recruiting

Rome, Georgia, United States, 30165

Contacts

AdventHealth Shawnee Mission

Recruiting

Shawnee Mission, Kansas, United States, 66204

Contacts

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

University of Mossouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Creighton University Medical Center

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

Suny Downstate

Recruiting

Brooklyn, New York, United States, 11203

Contacts

New York-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Shana Hayes, M.S.

cmc9055@nyp.org

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

CHRISTUS Trinity Mother Frances Health System

Recruiting

Tyler, Texas, United States, 75701

Contacts

Health University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

More Information

Sponsor

University of Rochester

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • arrhythmia
  • heart failure
  • ICD
  • implantable cardioverter defibrillator
  • ICD shock
  • carvedilol
  • metoprolol succinate
  • beta-blocker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-09-18.