Comparing Carvedilol and Metoprolol Succinate for Treating Heart Failure in Patients with an Implantable Cardioverter Defibrillator

What this Trial Is About

This trial investigates the comparative effectiveness of two beta-blocker drugs, carvedilol and metoprolol succinate, in adults with heart failure with reduced ejection fraction HFrEF who have an implantable cardioverter defibrillator ICD. The study aims to provide clear data on which medication better reduces the risk of ICD therapy, cardiovascular hospitalizations, or cardiovascular death. It is a prospective, multicenter, randomized clinical trial enrolling 2,000 participants across 100 U.S. sites, including an 18-month feasibility phase. Participants currently taking metoprolol succinate will be randomized to either continue this treatment or switch to carvedilol at an equivalent dose. Both groups will have their doses adjusted to the maximum tolerated level as per the study protocol. The feasibility phase will evaluate recruitment, safety, adherence, and retention, while the full study will follow participants for up to three years, assessing clinical outcomes and quality of life. During the study, participants will undergo regular assessments including ICD device checks, laboratory tests, imaging, and surveys on quality of life and anxiety related to ICD shocks. Data collected will include cardiovascular events, healthcare use, medication adherence, and patient-reported outcomes measured at baseline and throughout the follow-up. The trial will also analyze results by patient subgroups such as age, sex, race, heart failure type, and ICD type to better understand treatment responses.

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