Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Dietary Supplement: HVMN Ketone Ester
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized with worsening HF or de novo diagnosis of HF LVEF < 50% Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics. 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. If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-Hydroxybutyrate treatment<br>HVMN Ketone Ester 0,5 g / kg | Dietary Supplement: HVMN Ketone Ester<br>* Commercially available ketone supplement<br>|
| Placebo Comparator: Placebo Treatment<br>Maltodextrin-base isocaloric placebo | Dietary Supplement: Maltodextrin<br>* Commercially available maltodextrin supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 hours - Area under the curve |