NCT05655910 · Columbia University
Enhanced Nutritional Optimization in LVAD Trial
(ENOL)
What this study 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 side effects 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 randomly assigned 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.
View original scientific 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.
Interventions
DIETARY_SUPPLEMENT
Ensure Surgery Immunonutrition shake
Nutrition shake to support immune health and recovery from surgery.
Primary outcome measures
Change in Alpha Diversity (Baseline and Day 5)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in microbial gene count as measured in stool samples.
Change in Microbial Gene Count (Baseline and Pre-VAD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in biomarker CRP as measured in blood samples.
Change in C-Reactive Protein (CRP) (Baseline and Pre-VAD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in biomarker LPS as measured in blood samples.
Change in lipopolysaccharide (LPS) (Baseline and Pre-VAD)
Time frame: Baseline and Pre-VAD (approximately Day 0-5)
Change in biomarker LPS as measured in blood samples.
Change in lipopolysaccharide (LPS) (Baseline and Discharge)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in biomarker TNF as measured in blood samples.
Change in Tumor Necrosis Factor (TNF) (Baseline and Pre-VAD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in biomarker IL-6 as measured in blood samples.
Change in Interleukin 6 (IL-6) (Baseline and Pre-VAD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Day 5
Change in biomarker IL-10 as measured in blood samples.
Change in Interleukin 10 (IL-10) (Baseline and Pre-VAD)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Post-Discharge Follow-up (approximately Day 55)
Change in short-chain fatty acids as measured in blood samples.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- age \>18 years
- hospitalized
- undergoing LVAD therapy (enrolled at time of acceptance)
Exclusion criteria
- congenital heart disease
- infiltrative cardiomyopathy
- unable to tolerate oral nutrition
- surgery expected in \<5 days
Where
- New York, New York
Collaborators
Abbott Nutrition
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations