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NCT07434466Not yet recruiting

Ketone Ester for Treatment Of Acute Heart Failure

KETO-AHF: Ketone Ester for Treatment Of Acute Heart Failure: A Vanguard Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
15 Jan 2026
Start date
Sept 2026
Primary completion date
Jul 2027
Lead sponsor
University of Alberta
NCT number
NCT07434466

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Sept 2026 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Domain-Specific Inclusion Criteria:
  • 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
    • Domain-Specific Exclusion Criteria:
  • Type 1 diabetes mellitus
  • Patients on mechanical circulatory support
  • Patients on more than one inotrope or on inopressors
  • Patients on dialysis
  • Patients with non-functioning enteral tracks

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.