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OpenTrials
Completed

NCT Number: NCT05161650

Hemodynamic Effects of Chronic Ketosis.

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.

We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).

Presently there are no data on the clinical cardiovascular 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 cardiac function and exercise capacity in patients with HFrEF.

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Key information

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 (3-OHB)

Dietary Supplement

Commercially available ketone supplement

Placebo drink

Dietary Supplement

Isocaloric placebo

Primary outcomes

  1. Resting cardiac output (L/min)

    Time frame: 14 days of dietary supplement

    Measured with right heart catheterization

Secondary outcomes

  1. Resting pulmonary capillary wedge pressure (PCWP)

    Time frame: 14 days of dietary supplement

    Measured with right heart catheterization

  2. Peak exercise pulmonary capillary wedge pressure (PCWP)

    Time frame: 14 days of dietary supplement

    Measured with right heart catheterization

  3. Peak exercise cardiac output (L/min)

    Time frame: 14 days of dietary supplement

    Measured with right heart catheterization

  4. Exercise capacity (METs)

    Time frame: 14 days of dietary supplement

    Cardiopulmonary exercise test

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: Cardiovascular Effects

Acronym: KETO-CHF

Important dates

Study start
2022
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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