NCT05161650

Hemodynamic Effects of Chronic Ketosis.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone monoester (3-OHB)	Commercially available ketone supplement
DIETARY_SUPPLEMENT	Placebo drink	Isocaloric placebo

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2021-12-17
• Last updated: 2023-11-30

Locations

1 site across 1 country: Denmark