Actively Recruiting
Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Led by Institute for Clinical and Experimental Medicine · Updated on 2026-04-14
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 mmol/L. 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.
CONDITIONS
Brief Title
Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left ventricular ejection fraction less than 35%
- Acute heart failure with low cardiac output syndrome or cardiogenic shock
- Adults aged 18 years or older
You will not qualify if you...
- Severe liver failure
- Severe acidosis
- Inability to insert nasogastric tube
- Gastric paralysis or ileus
- Repeated vomiting
- Severe hypokalemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 hours
Participants receive a continuous infusion of ketone monoester via a nasogastric tube for 36 hours with frequent arterial blood concentration monitoring.
Continuous infusion with arterial blood concentration measurements every 1 to 3 hours
Duration - Up to 72 hours from start of infusion
Participants are monitored for safety outcomes including liver function, cardiac arrhythmias, and gastrointestinal tolerance after the infusion.
Assessments during 72 hours after treatment start
Trial Site Locations
Total: 1 location
1
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Prague, Czechia, 14021
Actively Recruiting
Research Team
M
Marek Sramko, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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