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Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
NCT06964464 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06964464 reports 13 study locations spanning 11 distinct geographic areas — top geographies include New York, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06964464?
The interventions under investigation include: Metoprolol Succinate (DRUG), Carvedilol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06964464?
This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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