Hemodynamic Effects of Chronic Ketosis.

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Ketone monoester (3-OHB); Dietary Supplement: Placebo drink

• Registration Number: NCT05161650
• 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-17
• Study Start: 2022-01-15
• Primary Completion: 2023-05-01
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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
Ketone monoester (3-OHB)	Ketone monoester (3-OHB)	-
Isocaloric placebo	Placebo drink	-

Primary Outcome Measures

Name	Time	Method
Resting cardiac output (L/min)	14 days of dietary supplement	Measured with right heart catheterization

Secondary Outcome Measures

Name	Time	Method
Peak exercise cardiac output (L/min)	14 days of dietary supplement	Measured with right heart catheterization
Resting pulmonary capillary wedge pressure (PCWP)	14 days of dietary supplement	Measured with right heart catheterization
Peak exercise pulmonary capillary wedge pressure (PCWP)	14 days of dietary supplement	Measured with right heart catheterization
Exercise capacity (METs)	14 days of dietary supplement	Cardiopulmonary exercise test

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark