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We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone Monoester | Experimental | Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) |
|
| Placebo Treatment | Placebo Comparator | Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm. |
|
| Ketone Monoester in presence of low-dose insulin clamp | Active Comparator | Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KetoneAid KE4 Pro Monoester | Dietary Supplement | A dietary supplement containing ketone monoester. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (L/min) | Change in Cardiac output measured by Swann-Ganz Catherization during study period, | 3 hours - Area under the curve |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | Change in LVEF measured by echocardiography during study periode | 3 hours - Area under the curve |
| Blood Ketones | Change in blood Ketones measured by venous blood samples |
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Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%
Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian H Christensen, MD | Contact | +4578452029 | krstchri@rm.dk | |
| Henrik S Wiggers, DMsci | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
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Patients are studied in a randomized single-blind cross-over design.
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| Science in Sport Go Enegy | Dietary Supplement | Dosis isocaloric to the KetoneAid Arm |
|
| 3 hours |
| Blood pH | Change in venous blood pH during the study period | 3 hours |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |