Study of Continuous Ketone Monoester Infusion via Nasogastric Tube for Adults with Severe Heart Failure

What this Trial Is About

Researchers are evaluating the feasibility and safety of using a continuous infusion of D-beta-hydroxybutyrate monoester through a nasogastric tube in adults with acutely decompensated heart failure who have a left ventricular ejection fraction LVEF less than 35%. The focus is on patients admitted to intensive care with low cardiac output syndrome or cardiogenic shock. This Phase 4 study aims to maintain therapeutic levels of beta-hydroxybutyrate to understand its effects in this critical condition. Participants will receive a continuous 36-hour infusion of the ketone monoester, with the infusion rate adjusted to keep arterial blood levels of 3-hydroxybutyrate between 2 and 3.5 mmolL. Blood concentrations will be monitored every 1 to 3 hours using point-of-care testing. The study assesses the proportion of time the ketone levels remain within the target range and evaluates safety outcomes, including liver function, cardiac arrhythmias, and gastrointestinal tolerance during and after the infusion. During the study, participants will have frequent blood tests to monitor ketone levels and liver function, along with observations for any heart rhythm changes or digestive issues. The main measurement is the time spent with ketone levels in the desired range over 36 hours. Safety will be followed for up to 72 hours from the start of treatment. The study is non-randomized and observational, involving patients actively receiving the ketone infusion, with close monitoring throughout the treatment period.

Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure