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Background:
Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure
Objectives:
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
Methods:
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
Perspectives:
The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | HVMN Ketone Ester 0,5 g / kg |
|
| Placebo Treatment | Placebo Comparator | Maltodextrin-base isocaloric placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVMN Ketone Ester | Dietary Supplement | Commercially available ketone supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output (L/min) | Right Heart Catherization | 3 hours - Area under the curve |
| Left Ventricular Ejection Fraction | Echocardiography | 3 hours - Area under the curve |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Outflow Tract Velocity Time Integral (cm) | Echocardiography | 3 hours - Area under the curve |
| Left Ventricular Filling Pressure (mmHg) | Right Heart Catherization |
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Inclusion Criteria:
Exclusion Criteria:
Cardiogenic shock
Systolic Blood Pressure <85 mmHg
Acute myocardial infarction other than type II <5 days prior to randomization *
Severe uncorrected cardiac valve disease
Expected or possible need for hemodialysis as judged by the investigator
Ongoing inotropic treatment
Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
Ongoing, severe infection
Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
Atrial Fibrillation with heart >120 beats per minute
Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian H Christensen, MD | Contact | 26603577 | kristianhylleberg@gmail.com | |
| 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 |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Commercially available maltodextrin supplement |
|
| 3 hours - Area under the curve |