Recruiting

Nutritional Optimization

Sponsor:

Columbia University

Code:

NCT05655910

Conditions

Heart Failure

Gut Microbiome

Nutritional Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ensure Surgery Immunonutrition shake

Study Details

Brief summary:

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

Heart Failure

Gut Microbiome

Nutritional Deficiency

Study ID

NCT05655910

Start date

Sep 22, 2022

Status verified date

Oct, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Ensure Surgery Immunonutrition shake

Nutrition shake to support immune health and recovery from surgery.

Primary outcome measure

  • Change in Alpha Diversity (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Alpha Diversity (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Alpha Diversity (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Alpha Diversity (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in Microbial Gene Count (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Microbial Gene Count (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Microbial Gene Count (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Microbial Gene Count (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in C-Reactive Protein (CRP) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in C-Reactive Protein (CRP) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in C-Reactive Protein (CRP) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in C-Reactive Protein (CRP) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in lipopolysaccharide (LPS) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in lipopolysaccharide (LPS) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in lipopolysaccharide (LPS) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in lipopolysaccharide (LPS) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in Tumor Necrosis Factor (TNF) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Tumor Necrosis Factor (TNF) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Tumor Necrosis Factor (TNF) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Tumor Necrosis Factor (TNF) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in Interleukin 6 (IL-6) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Interleukin 6 (IL-6) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Interleukin 6 (IL-6) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Interleukin 6 (IL-6) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in Interleukin 10 (IL-10) (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Interleukin 10 (IL-10) (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Interleukin 10 (IL-10) (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Interleukin 10 (IL-10) (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]
  • Change in Short-Chain Fatty Acids (Baseline and Day 5) [ Time Frame: Baseline and Day 5 ]
  • Change in Short-Chain Fatty Acids (Baseline and Pre-VAD) [ Time Frame: Baseline and Pre-VAD (approximately Day 0-5) ]
  • Change in Short-Chain Fatty Acids (Baseline and Discharge) [ Time Frame: Baseline and Discharge (approximately Day 25) ]
  • Change in Short-Chain Fatty Acids (Baseline and Post-Discharge Follow-up) [ Time Frame: Baseline and Post-Discharge Follow-up (approximately Day 55) ]

Central Contacts and Locations

Central contacts

Melana Yuzefpolskaya, MD

3472681454my2249@cumc.columbia.edu

Annamaria Ladanyi, MD

3322177467al4285@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Annamaria Ladanyi, MD

332-217-7467al4285@cumc.columbia.edu

Melana Yuzefpolskaya, MD

3472681454my2249@cumc.columbia.edu

Principal Investigator:

Melana Yuzefpolskaya, MD

More Information

Sponsor

Columbia University

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-31.