Randomised Controlled TrialiVNSn = 532

Vagal Nerve Stimulation in Patients With Heart Failure and Reduced Ejection Fraction: The ANTHEM-HFrEF Trial

Konstam MA, Udelson JE, Mann DL, DiCarlo L, Butler J, Ardell J, De Ferrari GM, Klein HU, Filippatos G, Metra M, et al.

JACC · 2026

Key finding

In this prematurely terminated pivotal trial of 532 HFrEF patients, the underpowered primary endpoint of cardiovascular death or heart failure hospitalization was neutral, with safety and autonomic engagement demonstrated and only hypothesis-generating trends in symptoms and function.

Condition
Heart Failure
Stimulation
iVNS
Evidence tier
Randomised Controlled Trial
Participants
532
View on DOI

Cite this study

Konstam, M. A., Udelson, J. E., Mann, D. L., DiCarlo, L., Butler, J., Ardell, J., De Ferrari, G. M., Klein, H. U., Filippatos, G., Metra, M., Anand, I., Close, N., Saville, B. R., Detry, M. A., Paulon, G., Khandwala, F., Bosse, A., KenKnight, B., Mindrebo, S., … Teerlink, J. R. (2026). Vagal Nerve Stimulation in Patients With Heart Failure and Reduced Ejection Fraction: The ANTHEM-HFrEF Trial. JACC, 87(25), 3490-3502. https://doi.org/10.1016/j.jacc.2026.03.040

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