Baroreflex activation therapy in heart failure - the Barostim-Enabled Neurohormonal Intervention for Improving Treatment of Heart Failure (BENEFIT-HF) trial rationale and design.

BACKGROUND

Baroreflex activation therapy (BAT) using an implanted neurostimulator enhances functional status and quality of life in patients with symptomatic heart failure with reduced ejection fraction (HFrEF). Nonetheless, its influence on mortality, heart failure morbidity, and optimal patient subgroups requires further study.

METHODS

BENEFIT-HF is a prospective, randomized, open-label trial recruiting patients with left ventricular ejection fraction (LVEF) <50% who remain symptomatic despite guideline-directed medical and device therapies. A total of 2500 eligible ambulatory patients with stable heart failure will be randomized 2:1 to BAT implantation (Barostim System, CVRx, Inc., Minneapolis, MN, USA) plus standard care (Treatment Group) or standard care alone (Control Group). The primary efficacy endpoint is a 24-month composite of all-cause mortality, left ventricular assist device implantation or heart transplantation, and recurrent heart failure events. Secondary endpoints encompass changes in health status via the Minnesota Living with Heart Failure Questionnaire, 6-minute hall walk distance, days lost due to death or hospitalization, N-terminal pro-B-type natriuretic peptide levels, and all-cause mortality.

CONCLUSIONS

BENEFIT-HF represents the largest device-based trial evaluating BAT as a neurohormonal modulator in a diverse cohort of HFrEF and heart failure with mildly reduced ejection fraction (HFmrEF) patients, aimed at determining its effects on morbidity, mortality, health status, and functional capacity.