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Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure

NCT06653725 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure (AHF)

Interventions

DIETARY_SUPPLEMENT

1,3-butanediol

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Viborg Regional Hospital

    collaborator OTHER

  • Hospitalsenhed Vest, Herning

    collaborator UNKNOWN

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Copenhagen University Hospital, Amager-Hvidovre, Denmark

    collaborator UNKNOWN

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Kristoffer Berg-Hansen, MD, PhD · Department of Cardiology, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-11-01
Completion
2028-01-01

Countries

  • Denmark

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 NCT06653725 on ClinicalTrials.gov