Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
LVEF <35%
Acute heart failure with low cardiac output syndrome or cardiogenic shock
Disqualifiers
Severe liver failure
Severe acidosis
Inability to insert nasogastric tube
Gastric paralysis / ileus
Trial design
Design model
Single group
Treatments tested in this trial
Ketone Monoester (KE)
Dietary supplementContinous infusion of a commercially available ketone monoester via nasogastric tube.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Treated patientsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
Worsening of liver function
Increase of ALT, AST or GGT \> 2x from baseline
Time frame
During 72 hours within from start of the study intervention2
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 studySponsors and contacts
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Source ClinicalTrials.gov