Effect of carvedilol on survival in severe chronic heart failure.
M Packer, A J Coats, M B Fowler...
https://pubmed.ncbi.nlm.nih.gov/11386263Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06964464
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
4 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 trial investigates the comparative effectiveness of two beta-blocker drugs, carvedilol and metoprolol succinate, in adults with heart failure with reduced ejection fraction (HFrEF) who have an implantable cardioverter defibrillator (ICD). The study aims to provide clear data on which medication better reduces the risk of ICD therapy, cardiovascular hospitalizations, or cardiovascular death. It is a prospective, multicenter, randomized clinical trial enrolling 2,000 participants across 100 U.S. sites, including an 18-month feasibility phase. Participants currently taking metoprolol succinate will be randomized to either continue this treatment or switch to carvedilol at an equivalent dose. Both groups will have their doses adjusted to the maximum tolerated level as per the study protocol. The feasibility phase will evaluate recruitment, safety, adherence, and retention, while the full study will follow participants for up to three years, assessing clinical outcomes and quality of life. During the study, participants will undergo regular assessments including ICD device checks, laboratory tests, imaging, and surveys on quality of life and anxiety related to ICD shocks. Data collected will include cardiovascular events, healthcare use, medication adherence, and patient-reported outcomes measured at baseline and throughout the follow-up. The trial will also analyze results by patient subgroups such as age, sex, race, heart failure type, and ICD type to better understand treatment responses.
CONDITIONS
Brief Title
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Implantable cardioverter defibrillator (ICD) implanted for primary prevention of HFrEF (ischemic or non-ischemic)
- Currently treated with metoprolol succinate and willing to switch to carvedilol
- Left ventricular ejection fraction (LVEF) less than 50% within the past 12 months
You will not qualify if you...
- Unwilling or unable to follow the study protocol
- Treatment with any beta-blocker other than metoprolol succinate or no beta-blocker treatment
- Known intolerance or contraindication to carvedilol
- Systolic blood pressure below 100 mmHg
- Enrollment in another clinical trial
- Inability or unwillingness to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 years
Participants are randomized to either continue metoprolol succinate or switch to carvedilol, with doses titrated to the recommended target doses. This phase assesses the comparative effectiveness of these beta-blockers in heart failure patients with an implantable cardioverter defibrillator.
Baseline visit, visits at weeks 2 and 4, then quarterly visits thereafter
Follow-up
Duration - Average of 3 years
Participants are monitored for cardiovascular events, ICD therapies, healthcare utilization, and quality of life during and after treatment.
Quarterly visits after initial treatment visits
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
Loading map...
Research Team
M
Mehmet Aktas, M.D.
N
Nicole Guerrero, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group.
M Packer, M R Bristow, J N Cohn...
https://pubmed.ncbi.nlm.nih.gov/8614419Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial.
Philip A Poole-Wilson, Karl Swedberg, John G F Cleland...
https://pubmed.ncbi.nlm.nih.gov/12853193Effect of Carvedilol vs Metoprolol on Atrial and Ventricular Arrhythmias Among Implantable Cardioverter-Defibrillator Recipients.
Alexander Diamond, Ilan Goldenberg, Arwa Younis...
https://pubmed.ncbi.nlm.nih.gov/37656097Impact of carvedilol and metoprolol on inappropriate implantable cardioverter-defibrillator therapy: the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy).
Martin H Ruwald, Abeer Abu-Zeitone, Christian Jons...
https://pubmed.ncbi.nlm.nih.gov/23770172Effect of metoprolol versus carvedilol on outcomes in MADIT-CRT (multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy).
Martin H Ruwald, Anne-Christine H Ruwald, Christian Jons...
https://pubmed.ncbi.nlm.nih.gov/23500269Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.
Mona Fiuzat, Daniel Wojdyla, Dalane Kitzman...
https://pubmed.ncbi.nlm.nih.gov/22560018