Therapeutic Ketosis for Heart Failure: A State-of-the-Art Review.
Nandan Kodur, Christopher Nguyen, W H Wilson Tang
https://pubmed.ncbi.nlm.nih.gov/40043832/Actively Recruiting
Led by Aarhus University Hospital · Updated on 2025-06-05
250
Participants Needed
8
Research Sites
8 weeks
Total Duration
Researchers are investigating the effects of an exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute heart failure AHF. Acute heart failure is a serious condition with high mortality rates, and current treatments have not significantly improved survival. This study aims to see if 1,3-butanediol can improve clinical outcomes by supporting heart energy use and function during acute episodes. Participants will be randomly assigned to receive either 1,3-butanediol Ketone-IQae or a taste-matched placebo. Both treatments are given as 118 mL servings three times daily for 30 days. The study is double-blind, meaning neither participants nor researchers know who receives the supplement or placebo. The trial includes a 30-day treatment period to compare the effects on heart function and patient health. Throughout the study, participants will undergo assessments of clinical benefit including death, heart failure events, and changes in physical performance measured by a six-minute walk test and NT-proBNP levels. Other evaluations include daily activity, heart function scores, symptoms, blood pressure, weight, medication use, and need for intensive care or dialysis. Safety and efficacy will be monitored closely during the 30-day treatment period to understand how the supplement affects acute heart failure outcomes.
CONDITIONS
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
K
Kristoffer Berg-Hansen, MD, PhD
H
Henrik Wiggers, MD, PHD, DMSc
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Aarhus University Hospital
Lead Sponsor
Viborg Regional Hospital
Collaborating Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 30 days
Participants receive either 1,3-butanediol dietary supplement or a placebo three times daily during hospitalization for acute heart failure.
Daily visits during hospitalization and treatment period
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nandan Kodur, Christopher Nguyen, W H Wilson Tang
https://pubmed.ncbi.nlm.nih.gov/40043832/Aarhus University Hospital
Lead Sponsor
Viborg Regional Hospital
Collaborating Sponsor