RecruitingPhase 2NCT06653725

Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure

Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure. A Randomized Clinical Trial (KETO-AHF)


Sponsor

Aarhus University Hospital

Enrollment

250 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-blind, placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute heart failure (AHF), potentially leading to better clinical outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ketone supplements (a type of energy source that the heart can use efficiently) can help patients who are hospitalized with acute heart failure — a sudden worsening of heart failure — by giving the weakened heart an alternative fuel source to improve its function. **You may be eligible if...** - You are 18 or older and admitted to the hospital specifically because of worsening heart failure - You have symptoms like severe shortness of breath at rest or with minimal activity, or extreme fatigue - Physical examination and lab results confirm your heart failure is worsening **You may NOT be eligible if...** - Your heart failure is a secondary issue (e.g., admitted primarily for another reason) - You are on dialysis or have very poor kidney function - You are pregnant - You have certain conditions that make the ketone supplement unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENT1,3-butanediol

1,3-butanediol (Ketone-IQ®) 118 mL (33 g) servings trice daily

DIETARY_SUPPLEMENTPlacebo

Taste-matched placebo (isovolumic, isoviscous water with stevia) 118 mL servings trice daily


Locations(8)

Department of Cardiology, Aalborg University Hospital

Aalborg, Denmark

Department of Cardiology, Aarhus University Hospital

Aarhus N, Denmark

Department of Cardiology, Herlev-Gentofte Hospital

Copenhagen, Denmark

Department of Cardiology, Rigshospitalet

Copenhagen, Denmark

Department of Cardiology, Gødstrup Hospital, Herning, Denmark

Herning, Denmark

Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre Hospital

Hvidovre, Denmark

Department of Cardiology, Odense University Hospital

Odense, Denmark

Department of Cardiology, Viborg Hospital

Viborg, Denmark

View Full Details on ClinicalTrials.gov

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NCT06653725


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