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Enhanced Nutritional Optimization in LVAD Trial
Enhanced Nutritional Optimization in LVAD (ENOL) Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * age \>18 years * hospitalized * undergoing LVAD therapy (enrolled at time of acceptance) Exclusion Criteria: * intubated * congenital heart disease * infiltrative cardiomyopathy * unable to tolerate oral nutrition * surgery expected in \<5 days
About the study
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.
What is being tested
- Ensure Surgery Immunonutrition shake (dietary supplement)
Sponsor: Columbia University · Participants: 50 · Started: Sep 22, 2022
Contact the study team
- Melana Yuzefpolskaya, MD · Phone: 3472681454
- Annamaria Ladanyi, MD · Phone: 3322177467
Official record on ClinicalTrials.gov — NCT05655910
Locations in the U.S.
| New York | Columbia University Medical Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.