Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Resting cardiac output (L/min)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Resting cardiac output (L/min)
Time Frame: 14 days of dietary supplement
Measured with right heart catheterization
Secondary Outcomes
- Peak exercise cardiac output (L/min)(14 days of dietary supplement)
- Resting pulmonary capillary wedge pressure (PCWP)(14 days of dietary supplement)
- Peak exercise pulmonary capillary wedge pressure (PCWP)(14 days of dietary supplement)
- Exercise capacity (METs)(14 days of dietary supplement)
Investigators
Kristoffer Berg-Hansen
Principal Investigator
University of Aarhus