Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05161676

Enrollment

Registered

2021-12-17

Start date

2021-12-15

Completion date

2023-10-01

Last updated

2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTKetone monoester

Commercially available ketone supplement

DIETARY_SUPPLEMENTPlacebo drink

Isocaloric placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Differences in lipolysis rate	14 days of dietary supplement	Measured as differences in palmitate flux

Secondary

Measure	Time frame	Description
Changes in protein metabolism	14 days of dietary supplement	Measured with a urea tracer
Changes in glucose kinetic	14 days of dietary supplement	Measured by glucose tracer

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026