Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator (NCT06964464)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: HonorHealth — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- HonorHealth — Scottsdale, Arizona
- AdventHealth Redmond — Rome, Georgia
- AdventHealth Shawnee Mission — Shawnee Mission, Kansas
- Henry Ford Health System — Detroit, Michigan
- University of Mossouri — Columbia, Missouri
- Creighton University Medical Center — Omaha, Nebraska
- Suny Downstate — Brooklyn, New York
- New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York
- University of Rochester Medical Center — Rochester, New York
- CHRISTUS Trinity Mother Frances Health System — Tyler, Texas
- Health University of Utah — Salt Lake City, Utah
- Virginia Commonwealth University — Richmond, Virginia
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (585) 275-5391
Email: Mehmet_Aktas@URMC.Rochester.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure With Reduced Ejection Fraction (HFrEF)
- Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction — Norfolk, Virginia
- A Trial of CRD-4730 in HFrEF — Pasadena, California
Explore by condition: All Heart Failure With Reduced Ejection Fraction (HFrEF) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.