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Ketone Ester for Treatment Of Acute Heart Failure
Sponsor: University of Alberta
Summary
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.
Official title: KETO-AHF: Ketone Ester for Treatment Of Acute Heart Failure: A Vanguard Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03
Completion Date
2028-03
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Ketone Ester (KetoneAid MonoEster)
Participants 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
Participants 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.
Locations (1)
University of Alberta
Edmonton, Alberta, Canada