Carvedilol versus metoprolol succinate in people with heart failure and an implanted defibrillator

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, open-label randomized trial will enroll 2,000 adults with heart failure with reduced ejection fraction (HFrEF) who have an implantable cardioverter defibrillator, with an initial 18-month feasibility phase of 100 participants at 15 sites. Eligible participants currently on metoprolol succinate will be randomized 1:1 to continue metoprolol succinate or switch to an equivalent dose of carvedilol, with dose titration as tolerated. Participants will be followed for up to three years with regular ICD interrogations, medication adherence monitoring, healthcare utilization tracking, and quality-of-life surveys. The primary outcome is a composite of first ICD therapy (appropriate or inappropriate), cardiovascular hospitalization, or cardiovascular death, and secondary outcomes include ICD shock burden and patient-reported outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 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 ßB than metoprolol succinate or no ßB treatment
* Known prior intolerance or contraindication to carvedilol
* Systolic blood pressure \<100 mmHg
* Enrollment in another clinical trial
* Inability or unwilling to consent

Where it's running

• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• AdventHealth Redmond
  Rome, Georgia, United States Recruiting
• AdventHealth Shawnee Mission
  Shawnee Mission, Kansas, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• University of Mossouri
  Columbia, Missouri, United States Recruiting
• Creighton University Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Mehmet Aktas, M.D.
• Email: Mehmet_Aktas@URMC.Rochester.edu
• Phone: 585-275-5391

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.