Hemodynamic Effects of Chronic Ketosis.

Heart Failure Clinical Trial

— KETO-CHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161650
• Other study ID #: KETO-CHF
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Ketone monoester (3-OHB)
Commercially available ketone supplement
• Placebo drink
Isocaloric placebo

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting cardiac output (L/min)	Measured with right heart catheterization	14 days of dietary supplement
Secondary	Resting pulmonary capillary wedge pressure (PCWP)	Measured with right heart catheterization	14 days of dietary supplement
Secondary	Peak exercise pulmonary capillary wedge pressure (PCWP)	Measured with right heart catheterization	14 days of dietary supplement
Secondary	Peak exercise cardiac output (L/min)	Measured with right heart catheterization	14 days of dietary supplement
Secondary	Exercise capacity (METs)	Cardiopulmonary exercise test	14 days of dietary supplement