Hemodynamic Effects of Chronic Ketosis. (KETO-CHF)

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Dietary Supplement: Placebo drink; Dietary Supplement: Ketone monoester (3-OHB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05161650

KETO-CHF

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

Ketone monoester (3-OHB)

Experimental group

Treatment:

Dietary Supplement: Ketone monoester (3-OHB)

Isocaloric placebo

Experimental group

Treatment:

Dietary Supplement: Placebo drink