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Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).
In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone ester | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone ester | Dietary Supplement | Commercially available ketone supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (L/min) | Right heart catheterization | 14 days ketone ester treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonal wedge capillary Pressure (PCWP) | Right heart catheterization | 14 days ketone ester treatment |
| Exercise capacity (METs) | Cardiopulmonary exercise test |
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Inclusion Criteria:
Type 2 diabetes
LVEF > 40 %
a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness > 12 mm) and/or previous myocardial infarction
age ≥ 18 years old,
one of the following criteria (a-d) should be fulfilled:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39162035 | Derived | Gopalasingam N, Berg-Hansen K, Christensen KH, Ladefoged BT, Poulsen SH, Andersen MJ, Borlaug BA, Nielsen R, Moller N, Wiggers H. Randomized Crossover Trial of 2-Week Ketone Ester Treatment in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction. Circulation. 2024 Nov 12;150(20):1570-1583. doi: 10.1161/CIRCULATIONAHA.124.069732. Epub 2024 Aug 20. |
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| Placebo drink |
| Dietary Supplement |
Isocaloric placebo |
|
| 14 days ketone ester treatment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
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| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
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