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Ketone Ester for Treatment Of Acute Heart Failure

NCT07434466 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Canadian VIGOUR Centre

    collaborator OTHER

  • University Hospital Foundation

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Fernando G Zampieri, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434466 on ClinicalTrials.gov