Key result
Baroreflex activation therapy faces standard care in a new trial for major heart failure events.
Why the study?
While baroreflex activation therapy improves functional status and quality of life in symptomatic HFrEF, its influence on mortality, heart failure morbidity, and optimal patient subgroups requires further study.
Does baroreflex activation therapy added to standard care reduce the composite of all-cause mortality, LVAD implantation, heart transplantation, and recurrent heart failure events in ambulatory patients with symptomatic heart failure and LVEF <50%?
RCT (n=2,500)
Open-label
2:1
Does baroreflex activation therapy added to standard care reduce the composite of all-cause mortality, LVAD implantation, heart transplantation, and recurrent heart failure events in ambulatory patients with symptomatic heart failure and LVEF <50%?
The BENEFIT-HF trial will evaluate whether baroreflex activation therapy improves morbidity, mortality, and functional capacity in patients with symptomatic heart failure and LVEF <50%.
May support baroreflex activation in heart failure; leaves open event reduction pending larger trials.
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 patients with HFrEF and heart failure with mildly reduced ejection fraction (HFmrEF), aimed at determining its effects on morbidity, mortality, health status, and functional capacity.
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Sheikh et al. (2026) conducted an RCT in Heart failure with reduced or mildly reduced ejection fraction (LVEF <50%) (n=2,500). Baroreflex activation therapy (BAT) implantation plus standard care vs. Standard care alone was evaluated on 24-month composite of all-cause mortality, left ventricular assist device implantation or heart transplantation, and recurrent heart failure events. Baroreflex activation therapy will be evaluated against standard care in 2,500 patients with heart failure and LVEF <50% for a 24-month composite of mortality, LVAD/transplant, and HF events.
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