Actively Recruiting
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Led by University of Rochester · Updated on 2025-09-18
2000
Participants Needed
13
Research Sites
306 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Implantable cardioverter defibrillator (ICD) implanted for primary prevention of heart failure with reduced ejection fraction (HFrEF) of ischemic or non-ischemic cause with remote monitoring capability
- Currently treated with metoprolol succinate and willing to switch to carvedilol
- Left ventricular ejection fraction (LVEF) less than 50% in the past 12 months before consent
You will not qualify if you...
- Unwilling or unable to follow the study protocol
- Treated with any beta-blocker other than metoprolol succinate or not treated with any beta-blocker
- Known intolerance or contraindication to carvedilol
- Systolic blood pressure less than 100 mmHg
- Currently enrolled in another clinical trial
- Unable or unwilling to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
AdventHealth Redmond
Rome, Georgia, United States, 30165
Actively Recruiting
3
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, United States, 66204
Actively Recruiting
4
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
5
University of Mossouri
Columbia, Missouri, United States, 65212
Actively Recruiting
6
Creighton University Medical Center
Omaha, Nebraska, United States, 68124
Actively Recruiting
7
Suny Downstate
Brooklyn, New York, United States, 11203
Actively Recruiting
8
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
9
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
10
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States, 75701
Actively Recruiting
11
Health University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
13
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
M
Mehmet Aktas, M.D.
CONTACT
N
Nicole Guerrero, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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