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NCT06964464 · ClinicalTrials.gov registry record · Phase 4
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
A Phase 4 study of Cardiomyopathy and Sudden Cardiac Death, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 2,000
- Enrollment target
- 13
- Study locations
NCT06964464 is a Phase 4 study of Cardiomyopathy and Sudden Cardiac Death that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 2,000 participants, above the 477-participant average among 25 other Cardiomyopathy trials with a reported enrollment target (319% higher). The trial reports 13 study locations across 11 states.
The verdict
NCT06964464, a Phase 4 study of Cardiomyopathy and Sudden Cardiac Death, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 2,000 participants
- Enrollment target
- 13
- Study locations
Study 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 Studied
Interventions
- DRUG Metoprolol Succinate
- DRUG Carvedilol
Study Locations (13)
New York
- Suny Downstate - Brooklyn
- New York-Presbyterian Brooklyn Methodist Hospital - Brooklyn
- University of Rochester Medical Center - Rochester
Arizona
- HonorHealth - Scottsdale
Georgia
- AdventHealth Redmond - Rome
Kansas
- AdventHealth Shawnee Mission - Shawnee Mission
Michigan
- Henry Ford Health System - Detroit
Missouri
- University of Mossouri - Columbia
Nebraska
- Creighton University Medical Center - Omaha
Texas
- CHRISTUS Trinity Mother Frances Health System - Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2025-08-17 |
| Est. Completion | 2031-07-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06964464
The ClinicalTrials.gov registry entry for NCT06964464 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 477-participant average among 25 other Cardiomyopathy trials with a reported enrollment target (319% higher). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Metoprolol Succinate is the first listed.
NCT06964464 reports 13 study locations spanning 11 distinct geographic areas - top geographies include New York, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT06964464 about?
NCT06964464 is a clinical study titled "Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator". 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 stu...
What is the current status of trial NCT06964464?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 2,000 participants. The study started on 2025-08-17. Estimated completion is 2031-07-01.
What conditions does trial NCT06964464 study?
This clinical trial studies the following conditions: Cardiomyopathy, Sudden Cardiac Death, Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD).
What interventions are being tested in trial NCT06964464?
The interventions under investigation include: Metoprolol Succinate (DRUG), Carvedilol (DRUG).
Who is sponsoring clinical trial NCT06964464?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06964464 being conducted?
This trial has 13 study locations across Arizona, Georgia, Kansas, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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