Enhanced Nutritional Optimization in LVAD Trial
Recruiting now · Not applicable
Conditions studied: Heart Failure, Gut Microbiome, Nutritional Deficiency
In brief
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.
Key facts
- Study ID
- NCT05655910
- Run by
- Columbia University
- People needed
- 50
- Starts
- 2022-09-22
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age >18 years
- hospitalized
- undergoing LVAD therapy (enrolled at time of acceptance)
You may not qualify if…
- intubated
- congenital heart disease
- infiltrative cardiomyopathy
- unable to tolerate oral nutrition
- surgery expected in <5 days
Where it is running
- Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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