Actively Recruiting
Enhanced Nutritional Optimization in LVAD Trial
Led by Columbia University · Updated on 2025-10-31
50
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Abbott Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enhanced Nutritional Optimization in LVAD Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Hospitalized
- Undergoing left ventricular assist device (LVAD) therapy (enrolled at time of acceptance)
You will not qualify if you...
- Currently intubated
- Having congenital heart disease
- Having infiltrative cardiomyopathy
- Unable to tolerate oral nutrition
- Surgery expected in less than 5 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Melana Yuzefpolskaya, MD
CONTACT
A
Annamaria Ladanyi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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