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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone monoester (3-OHB) | Experimental |
| |
| Isocaloric placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone monoester (3-OHB) | Dietary Supplement | Commercially available ketone supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resting cardiac output (L/min) | Measured with right heart catheterization | 14 days of dietary supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Resting pulmonary capillary wedge pressure (PCWP) | Measured with right heart catheterization | 14 days of dietary supplement |
| Peak exercise pulmonary capillary wedge pressure (PCWP) | Measured with right heart catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | DK-8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38533643 | Derived | Berg-Hansen K, Gopalasingam N, Christensen KH, Ladefoged B, Andersen MJ, Poulsen SH, Borlaug BA, Nielsen R, Moller N, Wiggers H. Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial. Circulation. 2024 May 7;149(19):1474-1489. doi: 10.1161/CIRCULATIONAHA.123.067971. Epub 2024 Mar 27. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo drink | Dietary Supplement | Isocaloric placebo |
|
| 14 days of dietary supplement |
| Peak exercise cardiac output (L/min) | Measured with right heart catheterization | 14 days of dietary supplement |
| Exercise capacity (METs) | Cardiopulmonary exercise test | 14 days of dietary supplement |