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/40043832Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06653725
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure. A Randomized Clinical Trial (KETO-AHF)
Led by Aarhus University Hospital · Updated on 2025-06-05
250
Participants Needed
8
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
V
Viborg Regional Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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-IQ ae) 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
Brief Title
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older admitted with acute heart failure as the primary diagnosis
- New or worsening symptoms due to heart failure including persistent breathlessness or fatigue
- Objective evidence of worsening heart failure with specific physical exam and laboratory findings
- Treatment with at least 40 mg intravenous furosemide or equivalent and/or vasoactive or inotropic drugs
- Left ventricular ejection fraction of 35% or higher measured during current hospitalization
- Elevated natriuretic peptides: NT-proBNP 600 pg/mL or BNP 150 pg/mL (higher if atrial fibrillation)
- Enrollment within first five days of hospital stay
You will not qualify if you...
- Hospitalization triggered by significant arrhythmia or unstable cardiogenic shock
- Likely or current use of mechanical circulatory support
- Recent cardiac surgery within 3 days
- Severe infections, anemia, COPD exacerbation, pulmonary embolism, or stroke
- Significant untreated valvular heart disease
- Planned cardiac resynchronization device implantation
- Severe kidney impairment or ongoing dialysis
- Certain heart diseases such as hypertrophic cardiomyopathy or myocarditis
- Type 1 diabetes
- Advanced liver disease (Child-Pugh class C)
- Cognitive impairment preventing informed consent
- Pregnancy or breastfeeding
- Inability to take oral substances or severe swallowing difficulties
- Serious gastrointestinal disease
- Adherence to ketogenic diet within 30 days prior to enrollment
- Awaiting heart transplantation
- Very severe lung disease or continuous home oxygen treatment
- Major comorbidities or health issues that could prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Treatment
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
Trial Site Locations
Total: 8 locations
1
Department of Cardiology, Aalborg University Hospital
Aalborg, Denmark
Not Yet Recruiting
2
Department of Cardiology, Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
3
Department of Cardiology, Herlev-Gentofte Hospital
Copenhagen, Denmark
Actively Recruiting
4
Department of Cardiology, Rigshospitalet
Copenhagen, Denmark
Not Yet Recruiting
5
Department of Cardiology, Gødstrup Hospital, Herning, Denmark
Herning, Denmark, 7400
Actively Recruiting
6
Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre Hospital
Hvidovre, Denmark
Actively Recruiting
7
Department of Cardiology, Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
8
Department of Cardiology, Viborg Hospital
Viborg, Denmark, 8800
Actively Recruiting
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Research Team
K
Kristoffer Berg-Hansen, MD, PhD
H
Henrik Wiggers, MD, PHD, DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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