Ketone Ester for Treatment Of Acute 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

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alberta

Lead sponsor

Canadian VIGOUR Centre

Collaborator

University Hospital Foundation

Collaborator