Heart failure & cardiomyopathiesRandomised controlled trial
Vagal Nerve Stimulation in Patients With Heart Failure and Reduced Ejection Fraction
- Randomised controlled trial
- 2:1 randomisation
- adaptive sample sizing
Authors' conclusion
The underpowered primary endpoint was neutral. Data documented feasibility, safety, and autonomic engagement. Trends favoring outcomes, symptoms, and function were inconclusive although hypothesis-generating.
Study context
- Population
- HFrEF, NYHA class II or III, left ventricular ejection fraction (LVEF) ≤35%, NT-proBNP ≥800 pg/mLenrollment terminated early
- Participants
- 532 participants
- Comparison
- Vagal nerve stimulation (VNS) vs control
- Primary endpoint
- Time to CV death or HF hospitalization
Primary result
As reported in the abstract
Primary efficacy endpoint not met
HR: 0.84; 95% CI: 0.62-1.12; P = 0.115
Secondary outcomes
Heart failure (HF) hospitalization, KCCQ, NYHA class, 6-minute walk distance
- Favorable, although inconclusive
LVEF
- Unchanged
Exploratory outcomes-symptoms win ratio (prespecified)
- Favorable but hypothesis-generating; marginal statistical significance
Safety
Freedom from procedure- or device-related serious adverse events (primary safety endpoint)
- Freedom from procedure- or device-related SAEs
- 96.7%
Original publication
Vagal Nerve Stimulation in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. Published 20 May 2026. doi:10.1016/j.jacc.2026.03.040
Summarised from the published abstract; every number is checked against it