Status:
RECRUITING
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Heart Failure With Reduced Ejection Fraction (HFrEF)
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The Comparative Effectiveness of Carvedilol versus Metoprolol Succinate in Heart Failure Patients with an Implantable Cardioverter Defibrillator (CARVTOP-ICD) study is a prospective, multicenter, open...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06964464
Start Date
August 17 2025
End Date
July 1 2031
Last Update
September 18 2025
Active Locations (13)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
AdventHealth Redmond
Rome, Georgia, United States, 30165
3
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, United States, 66204
4
Henry Ford Health System
Detroit, Michigan, United States, 48202