Ketone Ester for Treatment Of Acute Heart Failure
ConditionAcute Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects include energy provision for the failing heart and direct protective effects on other organs. Despite the strong physiological rationale, the acute effects of ketone therapy in patients with acute heart failure (AHF) is unclear. AHF is a major healthcare issue, with in-hospital mortality exceeding 10%. Therefore, we propose a vanguard randomized controlled trial to assess the effects of ketone esters in patients with AHF. Sixty patients hospitalized with AHF will be randomized to receive either 25 grams of ketone esters three times per day or a matching placebo for five days, or until death or hospital discharge. We hypothesize that ketone therapy will improve markers of systemic congestion and heart failure symptoms. Primary endpoint will be changes in NT-proBNP levels during therapy. Secondary endpoints will be KCCQ scores, and hemodynamic profile as assessed by echocardiogram. Exploratory endpoints will clinical outcomes including mortality, need for intensive care unit admission, among others.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of AHF with dyspnea on exertion or at rest, and at least two of the following: congestion on chest radiograph, rales on chest auscultation, clinically relevant edema, or an elevated jugular venous pressure [21]
Admitted to the hospital for less than 48 hours
Estimated glomerular filtration rate above 15 mL/min/1.73m²
NT-proBNP ≥ 1000 pg/ml
Disqualifiers
Type 1 diabetes mellitus
Patients on mechanical circulatory support
Patients on more than one inotrope or on inopressors
Patients on dialysis
Trial design
Design model
Sequential
Treatments tested in this trial
Ketone Ester (KetoneAid MonoEster)
Dietary supplementParticipants randomized to the intervention arm will receive KetoneAid MonoEster (D-β-hydroxybutyrate bonded to R-1,3-butanediol) administered orally or enterally at a dose of 25 g three times daily (total 75 g/day) for up to 5 consecutive days (or until discharge or death), in addition to standard of care acute heart failure management.
Placebo
Dietary supplementParticipants randomized to the control arm will receive a matching placebo administered orally or enterally three times daily for up to 5 consecutive days (or until discharge or death), in addition to standard of care acute heart failure management.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: KetoneAid MonoEsterExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in NT-proBNP
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level over the 5-day intervention period comparing ketone ester versus placebo.
Time frame
Baseline to Day 5 (or hospital discharge if earlier)Secondary outcomes
1
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score from baseline to Day 5 comparing treatment groups. The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) ranges from 0 to 100, where higher scores indicate fewer heart failure symptoms and better health status, and lower scores indicate more severe symptoms and worse health status.
Time frame
Baseline to Day 5 (or hospital discharge if earlier)2
Change in Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular ejection fraction from baseline to Day 5 comparing ketone ester versus placebo. Left ventricular ejection fraction is expressed as a percentage (%), with higher values indicating better systolic function.
Time frame
Baseline to Day 5 (or hospital discharge if earlier)3
Change in Mitral Inflow E/e' Ratio
Change in mitral inflow E/e' ratio from baseline to Day 5 comparing ketone ester versus placebo. E/e' ratio is a unitless measure of left ventricular filling pressure. Higher values indicate higher estimated filling pressures and worse diastolic function.
Time frame
Baseline to Day 5 (or hospital discharge if earlier)4
Change in Stroke Volume
Change in stroke volume from baseline to Day 5 comparing ketone ester versus placebo. Stroke volume is measured in milliliters (mL). Higher values indicate greater forward blood flow per heartbeat.
Time frame
Baseline to Day 5 (or hospital discharge if earlier)Other outcomes
1
Change in serum creatinine
Change in renal function measured by serum creatinine over the intervention period.
Time frame
Baseline to Day 5 (or discharge if earlier)2
Insulin requirements
Total insulin administered during the inpatient intervention period.
Time frame
Day 1 through Day 5 (or discharge if earlier)3
Glycemic control
Daily blood glucose measurements during the intervention period.
Time frame
Day 1 through Day 5 (or discharge if earlier)4
Days Alive and Out of Hospital
Number of days alive and out of hospital through Day 30 after randomization.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Canadian VIGOUR Centre
Collaborator
University Hospital Foundation
Collaborator
Source ClinicalTrials.gov
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