Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
University of Rochester
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.
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-label, two-arm, randomized clinical trial designed to assess the comparative effectiveness 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 a total of 2,000 participants from 100 sites across the United States, with an initial feasibility phase enrolling 100 pa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugMetoprolol Succinate
Metoprolol succinate is a beta-blocker used for the management of heart failure with reduced ejection fraction (HFrEF). In this study, participants in the metoprolol succinate group will remain on their current treatment regimen with metoprolol succinate. The dose will be titrated to the recommended target dose as per the study protocol. The intervention aims to evaluate the effectiveness of continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
- DrugCarvedilol
Carvedilol is a non-selective beta-blocker with alpha-blocking activity used in the treatment of heart failure. In this study, participants assigned to the carvedilol group will switch from metoprolol succinate to carvedilol at an equivalent dose. The carvedilol dose will be titrated to recommended target doses according to the study protocol. This intervention aims to compare the effectiveness of carvedilol versus metoprolol succinate in improving clinical outcomes in patients with heart failure and ICDs.
Locations (13)
- HonorHealthScottsdale, Arizona
- AdventHealth RedmondRome, Georgia
- AdventHealth Shawnee MissionShawnee Mission, Kansas
- Henry Ford Health SystemDetroit, Michigan
- University of MossouriColumbia, Missouri
- Creighton University Medical CenterOmaha, Nebraska