Enhanced Nutritional Optimization in LVAD Trial

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05655910
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ensure Surgery Immunonutrition shake — DIETARY_SUPPLEMENT
    Nutrition shake to support immune health and recovery from surgery.

Study Details

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 Dates

Start date
Sep 22, 2022
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1 (Not malnourished) - 3 products per day
    Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
  • Experimental: Group 1 (Not malnourished) - 1 product per day
    Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 1 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
  • Experimental: Group 2 (at risk/malnourished)
    Patients assessed as at risk for malnourishment or malnourished based on AND-ASPEN criteria automatically assigned to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.

Primary Outcome Measure

Change in Alpha Diversity (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Annamaria Ladanyi, MD
[email protected]
332-217-7467
Melana Yuzefpolskaya, MD
[email protected]
3472681454
Melana Yuzefpolskaya, MD (PRINCIPAL_INVESTIGATOR)
Paolo C Colombo, MD (SUB_INVESTIGATOR)
Ryan T Demmer, PhD (SUB_INVESTIGATOR)
Abigail Johnson, PhD, RDN (SUB_INVESTIGATOR)
Jennifer Cho, RD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Columbia University Medical Center· New York, NY

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