A Phase 4 interventional study of Ketone Monoester (KE) in Acute Heart Failure (AHF), Cardiogenic Shock and Heart Failure, sponsored by Institute for Clinical and Experimental Medicine. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Institute for Clinical and Experimental Medicine · Phase 4, Interventional, and Treatment
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.
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.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 12 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observational cohort of patients receiving 3-OHB
Dietary Supplement: Ketone Monoester (KE)
Continous infusion of a commercially available ketone monoester via nasogastric tube.
Proportion of time within the target concentration range
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
Time frame: 36 hours
Worsening of liver function
Increase of ALT, AST or GGT \> 2x from baseline
Time frame: During 72 hours within from start of the study intervention
GIT tolerance
Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion.
Time frame: During 36 hours of the study
Plan to share: No
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Studies of the drug tested here: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Institute for Clinical and Experimental Medicine