Project Title

Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure. A randomized clinical trial (KETO-AHF) 

Background

Acute heart failure is associated with high death and readmission rates, and contemporary medical treatments provide limited benefits in survival. Ketone bodies are efficient energy substrates to fuel the heart, especially during illness. Prior studies from our group show ketone therapy can improve heart function and reduce congestion, making it a promising therapy for hospitalized patients.

Aim

The overall aim of this study is to assess the effectiveness and safety of taking a ketone supplement three times daily compared with a placebo in patients hospitalized with acute heart failure. By exploring sustained ketone support as a bridge to long-term therapy during this critical stage, the trial seeks new ways to improve patient recovery and outcomes. 

Methods

This double-blind phase II trial will enroll 250 patients hospitalized with acute heart failure at multiple centers in Denmark. Participants are randomly assigned to take either a ketone drink (1,3-butanediol) or a taste-matched placebo three times daily for 30 days. We will track survival, heart failure events, exercise capacity, and heart stress markers, along with safety, symptoms, and quality of life.