Heart Failure Clinical Trial
— ENOLOfficial title:
Enhanced Nutritional Optimization in LVAD (ENOL) Trial
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Abbott Nutrition |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Alpha Diversity (Baseline and Day 5) | Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples. | Baseline and Day 5 | |
Primary | Change in Alpha Diversity (Baseline and Pre-VAD) | Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Alpha Diversity (Baseline and Discharge) | Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Alpha Diversity (Baseline and Post-Discharge Follow-up) | Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in Microbial Gene Count (Baseline and Day 5) | Change in microbial gene count as measured in stool samples. | Baseline and Day 5 | |
Primary | Change in Microbial Gene Count (Baseline and Pre-VAD) | Change in microbial gene count as measured in stool samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Microbial Gene Count (Baseline and Discharge) | Change in microbial gene count as measured in stool samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Microbial Gene Count (Baseline and Post-Discharge Follow-up) | Change in microbial gene count as measured in stool samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in C-Reactive Protein (CRP) (Baseline and Day 5) | Change in biomarker CRP as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in C-Reactive Protein (CRP) (Baseline and Pre-VAD) | Change in biomarker CRP as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in C-Reactive Protein (CRP) (Baseline and Discharge) | Change in biomarker CRP as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in C-Reactive Protein (CRP) (Baseline and Post-Discharge Follow-up) | Change in biomarker CRP as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Day 5) | Change in biomarker NT-proBNP as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Pre-VAD) | Change in biomarker NT-proBNP as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Discharge) | Change in biomarker NT-proBNP as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Post-Discharge Follow-up) | Change in biomarker NT-proBNP as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in lipopolysaccharide (LPS) (Baseline and Day 5) | Change in biomarker LPS as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in lipopolysaccharide (LPS) (Baseline and Pre-VAD) | Change in biomarker LPS as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in lipopolysaccharide (LPS) (Baseline and Discharge) | Change in biomarker LPS as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in lipopolysaccharide (LPS) (Baseline and Post-Discharge Follow-up) | Change in biomarker LPS as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in Tumor Necrosis Factor (TNF) (Baseline and Day 5) | Change in biomarker TNF as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in Tumor Necrosis Factor (TNF) (Baseline and Pre-VAD) | Change in biomarker TNF as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Tumor Necrosis Factor (TNF) (Baseline and Discharge) | Change in biomarker TNF as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Tumor Necrosis Factor (TNF) (Baseline and Post-Discharge Follow-up) | Change in biomarker TNF as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in Interleukin 6 (IL-6) (Baseline and Day 5) | Change in biomarker IL-6 as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in Interleukin 6 (IL-6) (Baseline and Pre-VAD) | Change in biomarker IL-6 as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Interleukin 6 (IL-6) (Baseline and Discharge) | Change in biomarker IL-6 as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Interleukin 6 (IL-6) (Baseline and Post-Discharge Follow-up) | Change in biomarker IL-6 as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in Interleukin 10 (IL-10) (Baseline and Day 5) | Change in biomarker IL-10 as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in Interleukin 10 (IL-10) (Baseline and Pre-VAD) | Change in biomarker IL-10 as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Interleukin 10 (IL-10) (Baseline and Discharge) | Change in biomarker IL-10 as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Interleukin 10 (IL-10) (Baseline and Post-Discharge Follow-up) | Change in biomarker IL-10 as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Primary | Change in Short-Chain Fatty Acids (Baseline and Day 5) | Change in short-chain fatty acids as measured in blood samples. | Baseline and Day 5 | |
Primary | Change in Short-Chain Fatty Acids (Baseline and Pre-VAD) | Change in short-chain fatty acids as measured in blood samples. | Baseline and Pre-VAD (approximately Day 0-5) | |
Primary | Change in Short-Chain Fatty Acids (Baseline and Discharge) | Change in short-chain fatty acids as measured in blood samples. | Baseline and Discharge (approximately Day 25) | |
Primary | Change in Short-Chain Fatty Acids (Baseline and Post-Discharge Follow-up) | Change in short-chain fatty acids as measured in blood samples. | Baseline and Post-Discharge Follow-up (approximately Day 55) | |
Secondary | Post-LVAD Infections | Number and type of infections experienced during index hospitalization following LVAD implantation | Day 25 | |
Secondary | Post-LVAD Length of Stay in intensive care unit | Number of days spent in intensive care unit following LVAD implantation. | Day 25 | |
Secondary | Post-LVAD Mortality | Number of participant deaths. | Up to 2 years |
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