Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
ConditionAcute Heart Failure (AHF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Documented new or worsening symptoms due to heart failure with at least one of the following: persistent dyspnea at rest or with minimal exertion, or fatigue.
Treatment with at least 40 mg of intravenous furosemide or its equivalent and/or intravenous vasoactive drugs and/or inotropic drugs.
An LVEF of ≤35% is required, measured during the present hospitalization.
Participants must present with elevated levels of natriuretic peptides, specifically NT-proBNP ≥600 pg/mL or BNP ≥150 pg/mL. For those in atrial fibrillation at the time of inclusion, NT-proBNP levels must be ≥900 pg/mL or BNP ≥225 pg/mL.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 1,3-butanediol
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aarhus University Hospital
Lead sponsor
Viborg Regional Hospital
Collaborator
Hospitalsenhed Vest, Herning
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Amager Hospital
Collaborator
Source ClinicalTrials.gov