Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05655910

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Hospitalized
  • Undergoing left ventricular assist device (LVAD) therapy (enrolled at time of acceptance)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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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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