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Nutritional Optimization for Heart Failure Patients Awaiting LVAD

This study is looking at whether a special nutrition shake, Ensure Surgery Immunonutrition, can help advanced heart failure patients who are waiting for an LVAD (Left Ventricular Assist Device, a mechanical pump that helps the heart pump blood). Researchers want to see if this shake, given before surgery, can improve the balance of gut bacteria (gut microbiome) and reduce inflammation and malnutrition often seen in these patients. The main goal is to see if the shake changes the gut microbiome's diversity between the start of the study and different time points, like before LVAD surgery and at discharge. You might be able to join if you are over 18, hospitalized, and have been accepted for LVAD therapy. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline up to discharge, which is approximately 25 days after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05655910

Enhanced Nutritional Optimization in LVAD Trial

Recruiting
NAAges 18+InterventionalPrevention
Columbia University
~50 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Ensure Surgery Immunonutrition shake

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Alpha Diversity (Baseline and Day 5)
Measured over Baseline and Day 5
+35 more outcomes measured

Conditions

Heart Failure
Gut Microbiome
Nutritional Deficiency

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Heart Failure

NCT05655910

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melana Yuzefpolskaya, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Melana Yuzefpolskaya, MD
[email protected]
3472681454
Email the study team

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Eligibility criteria

Inclusion

age \>18 years
hospitalized
undergoing LVAD therapy (enrolled at time of acceptance)

Exclusion

intubated
congenital heart disease
infiltrative cardiomyopathy
unable to tolerate oral nutrition
surgery expected in \<5 days

What this trial measures

  • Change in Alpha Diversity (Baseline and Day 5)Baseline and Day 5

    Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.

  • Change in Alpha Diversity (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.

  • Change in Alpha Diversity (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.

  • Change in Alpha Diversity (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.

  • Change in Microbial Gene Count (Baseline and Day 5)Baseline and Day 5

    Change in microbial gene count as measured in stool samples.

  • Change in Microbial Gene Count (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in microbial gene count as measured in stool samples.

  • Change in Microbial Gene Count (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in microbial gene count as measured in stool samples.

  • Change in Microbial Gene Count (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in microbial gene count as measured in stool samples.

  • Change in C-Reactive Protein (CRP) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker CRP as measured in blood samples.

  • Change in C-Reactive Protein (CRP) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker CRP as measured in blood samples.

  • Change in C-Reactive Protein (CRP) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker CRP as measured in blood samples.

  • Change in C-Reactive Protein (CRP) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker CRP as measured in blood samples.

  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker NT-proBNP as measured in blood samples.

  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker NT-proBNP as measured in blood samples.

  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker NT-proBNP as measured in blood samples.

  • Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker NT-proBNP as measured in blood samples.

  • Change in lipopolysaccharide (LPS) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker LPS as measured in blood samples.

  • Change in lipopolysaccharide (LPS) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker LPS as measured in blood samples.

  • Change in lipopolysaccharide (LPS) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker LPS as measured in blood samples.

  • Change in lipopolysaccharide (LPS) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker LPS as measured in blood samples.

  • Change in Tumor Necrosis Factor (TNF) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker TNF as measured in blood samples.

  • Change in Tumor Necrosis Factor (TNF) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker TNF as measured in blood samples.

  • Change in Tumor Necrosis Factor (TNF) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker TNF as measured in blood samples.

  • Change in Tumor Necrosis Factor (TNF) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker TNF as measured in blood samples.

  • Change in Interleukin 6 (IL-6) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker IL-6 as measured in blood samples.

  • Change in Interleukin 6 (IL-6) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker IL-6 as measured in blood samples.

  • Change in Interleukin 6 (IL-6) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker IL-6 as measured in blood samples.

  • Change in Interleukin 6 (IL-6) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker IL-6 as measured in blood samples.

  • Change in Interleukin 10 (IL-10) (Baseline and Day 5)Baseline and Day 5

    Change in biomarker IL-10 as measured in blood samples.

  • Change in Interleukin 10 (IL-10) (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in biomarker IL-10 as measured in blood samples.

  • Change in Interleukin 10 (IL-10) (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in biomarker IL-10 as measured in blood samples.

  • Change in Interleukin 10 (IL-10) (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in biomarker IL-10 as measured in blood samples.

  • Change in Short-Chain Fatty Acids (Baseline and Day 5)Baseline and Day 5

    Change in short-chain fatty acids as measured in blood samples.

  • Change in Short-Chain Fatty Acids (Baseline and Pre-VAD)Baseline and Pre-VAD (approximately Day 0-5)

    Change in short-chain fatty acids as measured in blood samples.

  • Change in Short-Chain Fatty Acids (Baseline and Discharge)Baseline and Discharge (approximately Day 25)

    Change in short-chain fatty acids as measured in blood samples.

  • Change in Short-Chain Fatty Acids (Baseline and Post-Discharge Follow-up)Baseline and Post-Discharge Follow-up (approximately Day 55)

    Change in short-chain fatty acids as measured in blood samples.