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โ† Trials
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Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability * Current treatment with metoprolol succinate and willing to switch to carvedilol * LVEF \<50% during the past 12 months prior to consent Exclusion Criteria: * Unwilling or unable to follow the protocol * Treatment with any other รŸB than metoprolol succinate or no รŸB treatment * Known prior intolerance or contraindication to carvedilol * Systolic blood pressure \<100 mmHg * Enrollment in another clinical trial * Inability or unwilling to consent
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What it tests

  • Metoprolol Succinate
  • Carvedilol
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Where

13 sites
HonorHealth
Scottsdale, United States
AdventHealth Redmond
Rome, United States
AdventHealth Shawnee Mission
Shawnee Mission, United States
Henry Ford Health System
Detroit, United States
University of Mossouri
Columbia, United States
Creighton University Medical Center
Omaha, United States
Suny Downstate
Brooklyn, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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