Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure, Ketone Body Metabolism, Ketones
Conditions
Keywords
acute heart failure, ketones, ketone body
Brief summary
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
Detailed description
Adult patients with left ventricular ejection fraction (LVEF) \<35% admitted to the intensive care unit for acutely decompensated heart failure with low cardiac output syndrome or cardiogenic shock will receive a continuous infusion of D-3-hydroxybutyrate (3-OHB) monoester via a nasogastric tube for 36 hours. The infusion rate will be iteratively adjusted to achieve an arterial blood concentration of 3-OHB of 2-3.5 mmol/L. Arterial blood concentrations of 3-OHB will be measured every 1-3 hours using point-of-care testing. The primary endpoint will be the proportion of time within the target concentration range. Secondary safety endpoints will include worsening of liver function not attributable to hemodynamic deterioration, occurrence of cardiac arrhythmias, and gastrointestinal tolerance of the infusion.
Interventions
DIETARY_SUPPLEMENTKetone Monoester (KE)
Continous infusion of a commercially available ketone monoester via nasogastric tube.
Sponsors
Institute for Clinical and Experimental Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* LVEF \<35% * Acute heart failure with low cardiac output syndrome or cardiogenic shock
Exclusion criteria
* Severe liver failure * Severe acidosis * Inability to insert nasogastric tube * Gastric paralysis / ileus * Repeated vomiting * Severe hypokalemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of time within the target concentration range | 36 hours | Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worsening of liver function | During 72 hours within from start of the study intervention | Increase of ALT, AST or GGT \> 2x from baseline |
| GIT tolerance | During 36 hours of the study | Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion. |
Countries
Czechia
Contacts
CONTACTMarek Sramko, MD, PhD
Outcome results
None listed