The KETO-AHF trial is designed to randomize 250 patients hospitalized for acute heart failure to 30 days of 1,3-butanediol or placebo to evaluate a hierarchical composite of clinical outcomes.
RCT (n=250)
Double-blind
1:1
Yes
Does 1,3-butanediol improve a hierarchical composite of mortality, heart failure rehospitalization, 6-minute walk test, and NT-proBNP levels in patients hospitalized for acute heart failure with reduced ejection fraction?
The KETO-AHF trial will determine if 30-day exogenous ketone supplementation with 1,3-butanediol improves clinical and functional outcomes in patients hospitalized for acute heart failure with reduced ejection fraction.
BACKGROUND: Acute heart failure (AHF) is associated with high mortality rates, and contemporary medical treatments provide limited benefits in survival. Emerging evidence suggests that exogenous ketone bodies may have beneficial cardiovascular effects in patients with heart failure. The KETO-AHF (KETOne Supplements in Patients Hospitalized for Acute Heart Failure) trial is designed to assess the clinical benefits of initiating ketone supplementation with 1,3-butanediol compared with placebo in patients hospitalized for AHF with reduced ejection fraction. METHODS: KETO-AHF is a multicenter, randomized, double-blind, placebo-controlled trial investigating the effects of 1,3-butanediol (33 g 3 times daily) in patients hospitalized for AHF. Patients with symptoms and signs of AHF requiring intravenous loop diuretics and/or vasoactive treatment, elevated natriuretic peptides, and a left ventricular ejection fraction ≤ 35%, whether de novo or known heart failure, will be enrolled within 5 days of hospital admission. Participants will be randomized 1:1 to receive either 1,3-butanediol or placebo for a 30-day treatment period. The study aims to enroll 125 patients in each group. The primary endpoint is a hierarchical composite of all-cause mortality, heart failure rehospitalization, 6-minute walk test improvement, and reduction in NT-proBNP levels at 30 days. CONCLUSION: The KETO-AHF trial will provide insights into the effects of supplementation with the ketone body 1,3-butanediol in patients hospitalized for AHF.
Berg‐Hansen et al. (2025) conducted an RCT in Acute heart failure (n=250). 1,3-butanediol vs. Placebo was evaluated on Hierarchical composite of all-cause mortality, heart failure rehospitalization, 6-minute walk test improvement, and reduction in NT-proBNP levels at 30 days. The KETO-AHF trial is designed to randomize 250 patients hospitalized for acute heart failure to 30 days of 1,3-butanediol or placebo to evaluate a hierarchical composite of clinical outcomes.