Institute for Clinical and Experimental Medicine (IKEM)
Prague, 14021, Czechia
Location status: Recruiting
NCT Number: NCT07527156
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Prague, 14021, Czechia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continous infusion of a commercially available ketone monoester via nasogastric tube.
Time frame: 36 hours
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
Time frame: During 72 hours within from start of the study intervention
Increase of ALT, AST or GGT > 2x from baseline
Time frame: During 36 hours of the study
Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion.
Contact information is provided by the study sponsor or research team.
Institute for Clinical and Experimental Medicine
Other Gov
Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Acronym: KADHEF-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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