Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

NCT05161676 | Completed Phase 2 DMC

• 1 other identifier: KETO-CHF Metabolic
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Differences in lipolysis rate

  Measured as differences in palmitate flux

  14 days of dietary supplement

Secondary Outcomes (2)

• Changes in protein metabolism

  14 days of dietary supplement

• Changes in glucose kinetic

  14 days of dietary supplement

Study Arms (2)

Ketone monoester (3-OHB)

EXPERIMENTAL

Dietary Supplement: Ketone monoester

Placebo Treatment

EXPERIMENTAL

Dietary Supplement: Placebo drink

Interventions

Ketone monoester DIETARY_SUPPLEMENT

Commercially available ketone supplement

Ketone monoester (3-OHB)

Placebo drink DIETARY_SUPPLEMENT

Isocaloric placebo

Placebo Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: December 15, 2021
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DK (1)