Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: Ketone monoester

• Registration Number: NCT05161676
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study Start: 2021-12-15
• Study First Posted: 2021-12-17
• Primary Completion: 2023-05-01
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Treatment	Placebo drink	-
Ketone monoester (3-OHB)	Ketone monoester	-

Primary Outcome Measures

Name	Time	Method
Differences in lipolysis rate	14 days of dietary supplement	Measured as differences in palmitate flux

Secondary Outcome Measures

Name	Time	Method
Changes in glucose kinetic	14 days of dietary supplement	Measured by glucose tracer
Changes in protein metabolism	14 days of dietary supplement	Measured with a urea tracer

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark