Heart Failure
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone monoester (3-OHB)
Commercially available ketone supplement
DIETARY_SUPPLEMENTPlacebo drink
Isocaloric placebo
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting cardiac output (L/min) | 14 days of dietary supplement | Measured with right heart catheterization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Peak exercise cardiac output (L/min) | 14 days of dietary supplement | Measured with right heart catheterization |
| Exercise capacity (METs) | 14 days of dietary supplement | Cardiopulmonary exercise test |
Countries
Denmark
Outcome results
None listed