The CARVTOP-ICD trial addresses a key evidence gap in the management of patients with heart failure with reduced ejection fraction (HFrEF) who have an implanted cardioverter-defibrillator (ICD). Both metoprolol succinate and carvedilol are Guideline-recommended beta-blockers in HFrEF that improve survival and reduce cardiovascular events. However, there is clinical equipoise regarding their comparative effects on arrhythmic outcomes, cardiovascular hospitalization and survival. Prior observational studies have suggested possible differences in arrhythmia burden and clinical outcomes between these agents, but these findings are not definitive and were not derived from prospective randomized studies.

The CARVTOP-ICD trial is a prospective, multicenter, open-label, randomized comparative effectiveness study designed to rigorously compare carvedilol versus metoprolol succinate in patients with HFrEF and an ICD. The trial will enroll 2,000 participants, randomized 1:1 to either continue metoprolol succinate or switch to carvedilol, with titration to maximally tolerated doses. The primary composite endpoint includes first ICD therapy (appropriate or inappropriate), cardiovascular hospitalization, or cardiovascular death. Secondary outcomes include shock burden, healthcare utilization, and patient-reported quality of life measures.

This trial will generate high-quality comparative effectiveness data to inform beta-blocker selection in a real-world HFrEF population with ICDs, addressing an important gap in evidence that may influence personalized treatment strategies and improve arrhythmic and clinical outcomes.

Additional information on the clinicaltrials.gov website.