Acute Heart Failure
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHVMN Ketone Ester
Commercially available ketone supplement
DIETARY_SUPPLEMENTMaltodextrin
Commercially available maltodextrin supplement
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output (L/min) | 3 hours - Area under the curve | Right Heart Catherization |
| Left Ventricular Ejection Fraction | 3 hours - Area under the curve | Echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Outflow Tract Velocity Time Integral (cm) | 3 hours - Area under the curve | Echocardiography |
| Left Ventricular Filling Pressure (mmHg) | 3 hours - Area under the curve | Right Heart Catherization |
Countries
Denmark
Contacts
Primary ContactKristian H Christensen, MD
Backup ContactHenrik S Wiggers, DMsci
Outcome results
None listed