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
Qualifiers
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
Treatments tested in this trial
- Ketone Ester (KetoneAid MonoEster)
- Placebo
Treatment groups
Sponsors and collaborators
University of Alberta
Lead sponsor
Canadian VIGOUR Centre
Collaborator
University Hospital Foundation
Collaborator