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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: Recruiting Phase 4 study of Cardiomyopathy and Sudden Cardiac Death, sponsored by University of Rochester.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

This composite outcome measures the time to first occurrence of one of the following events: (1) ICD therapy (appropriate or inappropriate shocks or anti-tachycardia pacing), (2) hospitalization due to cardiovascular causes, or (3) cardiovascular death. Only the first event occurring during the study period will be counted per participant.

Conditions Studied

Cardiomyopathy Sudden Cardiac Death Heart Failure With Reduced Ejection Fraction (HFrEF) Ventricular Arrhythmia Implantable Cardioverter Defibrillator (ICD) Beta-blocker Therapy

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

FieldValue
Enrollment Target 2,000 participants
Start Date 2025-08-17
Est. Completion 2031-07-01
Phase Phase 4
University of Rochester

636 total trials

What NCT06964464 shows while recruiting

NCT06964464 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 477-participant average among 25 other Cardiomyopathy trials with a reported enrollment target (319% higher).

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 lists 13 locations in 11 states (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.

Learn More About Clinical Trials

Similar trials for Cardiomyopathy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06964464's enrollment target sits among peer trials

2,000 2nd of 25 higher than 23 of 25 other Cardiomyopathy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiomyopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06964464

Source: ClinicalTrials.gov NCT06964464, the US trial registry maintained by the National Library of Medicine. NCT06964464 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.