RECRUITING

Enhanced Nutritional Optimization in LVAD Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhanced Nutritional Optimization in LVAD (ENOL) Trial

Quick Facts

Study Start:2022-09-22
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05655910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age \>18 years
  2. * hospitalized
  3. * undergoing LVAD therapy (enrolled at time of acceptance)
  1. * intubated
  2. * congenital heart disease
  3. * infiltrative cardiomyopathy
  4. * unable to tolerate oral nutrition
  5. * surgery expected in \<5 days

Contacts and Locations

Study Contact

Melana Yuzefpolskaya, MD
CONTACT
3472681454
my2249@cumc.columbia.edu
Annamaria Ladanyi, MD
CONTACT
3322177467
al4285@cumc.columbia.edu

Principal Investigator

Melana Yuzefpolskaya, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Melana Yuzefpolskaya, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-22
Study Completion Date2026-01

Study Record Updates

Study Start Date2022-09-22
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Left Ventricular Assist Device (LVAD)
  • Advanced Heart Failure
  • Mechanical Circulatory Support
  • Infection
  • Gut Microbiome

Additional Relevant MeSH Terms

  • Heart Failure
  • Gut Microbiome
  • Nutritional Deficiency