Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Acute Heart Failure (AHF)
In brief
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.
Key facts
- Study ID
- NCT06653725
- Run by
- Aarhus University Hospital
- People needed
- 250
- Starts
- 2025-03-20
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Current hospitalization for AHF triggered by significant arrhythmia (atrial fibrillation/flutter with sustained ventricular response \>110 beats per minute, clinically significant bradycardia, or sustained ventricular tachycardia)
- Cardiogenic shock in INTERMACS level 1 or 2 (i.e. unstable hemodynamics despite inotropic/vasopressor therapy)
- Likelihood or current use of mechanical circulatory support
- Recent cardiac surgery within 3 days
- Ongoing severe infection or sepsis, severe anemia, acute exacerbation of chronic obstructive pulmonary disease, pulmonary embolism, or cerebrovascular accident
- Significant primary valvular disease (hemodynamically severe uncorrected primary cardiac valvular disease)
- Planned implantation of a cardiac resynchronization therapy device
- eGFR \<15 mL/min/1.73 m2 during current hospitalization (unless ongoing continuous renal replacement therapy) or recurring dialysis
- Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the treating physician
- Type 1 diabetes
- Advanced liver disease (Child-Pugh class C)
- Dementia or other cognitive disorder making the patient unable to give informed consent
- Pregnancy or breastfeeding
- Inability to intake oral substances or severe dysphagia
- Significant gastrointestinal disease (i.e. severe inflammatory bowel disease or gastric ulcer)
- Adherent to a ketogenic diet within 30 days of enrollment
- Awaiting cardiac transplantation
- Very severe lung disease and/or treatment with continuous home oxygen therapy
- Major comorbidity, medical condition, or health issue that, according to the investigator's judgment, would hinder the participant's capacity to engage in or successfully finish the study
Where it is running
- Department of Cardiology, Viborg Hospital — Viborg, Denmark (enrolling)
- Department of Cardiology, Aarhus University Hospital — Aarhus N, Denmark (enrolling)
- Department of Cardiology, Herlev-Gentofte Hospital — Copenhagen, Denmark (enrolling)
- Department of Cardiology, Gødstrup Hospital, Herning, Denmark — Herning, Denmark (enrolling)
- Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre Hospital — Hvidovre, Denmark (enrolling)
- Department of Cardiology, Aalborg University Hospital — Aalborg, Denmark
- Department of Cardiology, Rigshospitalet — Copenhagen, Denmark
- Department of Cardiology, Odense University Hospital — Odense, Denmark
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.