Actively Recruiting
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Led by Aarhus University Hospital · Updated on 2025-06-05
250
Participants Needed
8
Research Sites
145 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
This is a multicenter, randomized, double-blind, placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute heart failure (AHF), potentially leading to better clinical outcomes.
CONDITIONS
Official Title
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older admitted with acute heart failure as the main diagnosis
- New or worsening heart failure symptoms including persistent breathlessness at rest or with minimal exertion, or fatigue
- Objective evidence of worsening heart failure shown by at least two physical signs of fluid retention or poor organ perfusion, or one physical sign plus laboratory or imaging criteria
- Treatment with at least 40 mg intravenous furosemide or equivalent, and/or intravenous 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 (or higher thresholds if in atrial fibrillation)
- Enrollment within first five days of hospital stay
You will not qualify if you...
- Hospitalization triggered by significant arrhythmias such as atrial fibrillation/flutter with high ventricular rate, significant bradycardia, or sustained ventricular tachycardia
- Cardiogenic shock with unstable hemodynamics despite inotropic or vasopressor therapy
- Use or planned use of mechanical circulatory support
- Cardiac surgery within past 3 days
- Severe ongoing infection, sepsis, severe anemia, acute COPD exacerbation, pulmonary embolism, or stroke
- Severe uncorrected primary valvular heart disease
- Planned implantation of cardiac resynchronization therapy device
- Estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73 m2 during hospitalization unless on continuous renal replacement therapy, or recurring dialysis
- Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of heart failure, acute myocarditis, or constrictive pericarditis
- Type 1 diabetes
- Advanced liver disease (Child-Pugh class C)
- Dementia or cognitive disorder preventing informed consent
- Pregnancy or breastfeeding
- Inability to take oral substances or severe swallowing difficulties
- Significant gastrointestinal diseases such as severe inflammatory bowel disease or gastric ulcer
- Following a ketogenic diet within 30 days before enrollment
- Awaiting cardiac transplantation
- Very severe lung disease or continuous home oxygen therapy
- Major comorbidities or conditions that may prevent participation or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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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
Research Team
K
Kristoffer Berg-Hansen, MD, PhD
CONTACT
H
Henrik Wiggers, MD, PHD, DMSc
CONTACT
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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