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Completed

NCT Number: NCT05161676

Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.

Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital

Aarhus, DK-8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic heart failure with NYHA II-III
  • Left ventricular ejection fraction ≤40%
  • Negative urine-HCG for women with childbearing potential

Exclusion criteria

  • Known diabetes or HbA1c ≥48 mmol/mol
  • Significant cardiac valve disease
  • Severe stable angina pectoris
  • Age <18 years

Treatment and study plan

Ketone monoester

Dietary Supplement

Commercially available ketone supplement

Placebo drink

Dietary Supplement

Isocaloric placebo

Primary outcomes

  1. Differences in lipolysis rate

    Time frame: 14 days of dietary supplement

    Measured as differences in palmitate flux

Secondary outcomes

  1. Changes in protein metabolism

    Time frame: 14 days of dietary supplement

    Measured with a urea tracer

  2. Changes in glucose kinetic

    Time frame: 14 days of dietary supplement

    Measured by glucose tracer

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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