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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
1,3-butanediol
Dietary supplement1,3-butanediol (Ketone-IQ®) 118 mL (33 g) servings trice daily
Placebo
Dietary supplementTaste-matched placebo (isovolumic, isoviscous water with stevia) 118 mL servings trice daily
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: 1,3-butanediolExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in clinical benefit during 1,3-butanediol treatment versus placebo
Clinical benefit is defined through a hierarchical composite endpoint, using a win ratio, from day 0 to 30 in all-cause death and time to death, number of and time to heart failure events, ≥30 meters increase in the change from baseline to follow-up at 30 days in the 6MWT, (iv) \>30% decrease in the change from baseline to follow-up at 30 days in NT-proBNP, and (v) % decrease in NT-proBNP (continuous variable). The primary endpoint will be evaluated using a win ratio, in an intention-to-treat approach, with participants analyzed within the treatment groups to which they were originally randomized. The win ratio method involves a pairwise hierarchical comparison of each participant against all others and is determined by dividing the total number of wins achieved by participants in the 1,3-butanediol group by the total number of losses.
Time frame
From baseline (day 0) to end of treatment (day 30)Secondary outcomes
1
Time to all-cause death
Time frame
From baseline (day 0) to end of treatment (day 30)2
Time to first heart failure event
Time frame
From baseline (day 0) to end of treatment (day 30)3
Change in six-minute walking distance
Time frame
From baseline (day 0) to end of treatment (day 30)4
Change in daily activity level
When discharged, a wearable triaxial accelerometer will be placed around the wrist of the patient. The accelerometer will measure daily physical activity (milligravitational units) between discharge and 30-day follow-up.
Time frame
From discharge, day 30, and end of treatment (day 30)Other outcomes
1
Length of index hospital stay
Time frame
From baseline (day 0) to end of treatment (day 30)2
Days alive out of hospital
Time frame
From baseline (day 0) to end of treatment (day 30)3
Subject experiencing improvement/deterioration in NYHA Class
Time frame
From baseline (day 0) to discharge, day 30, and end of treatment (day 30)4
Change in estimated glomerular filtration rate
Pre-Specified Renal sub study
Time frame
From baseline (day 0) to discharge and end of treatment (day 30)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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