RecruitingNot ApplicableNCT05655910

Enhanced Nutritional Optimization in LVAD Trial

Enhanced Nutritional Optimization in LVAD (ENOL) Trial


Sponsor

Columbia University

Enrollment

50 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an enhanced, personalized nutrition program improves recovery and outcomes for patients who are hospitalized and receiving a left ventricular assist device (LVAD) — a mechanical pump implanted in the chest to help a failing heart pump blood. Many LVAD patients are malnourished, and this study aims to see if better nutritional support before and after implantation leads to better health outcomes. **You may be eligible if...** - You are over 18 years old - You are currently hospitalized and receiving or about to receive an LVAD - You are able to eat food by mouth **You may NOT be eligible if...** - You are on a mechanical ventilator (breathing machine) - You have congenital heart disease (a heart condition present from birth) - You have infiltrative cardiomyopathy (conditions like cardiac amyloidosis or sarcoidosis that infiltrate the heart muscle) - You are unable to tolerate oral food or nutrition - You are expected to have another surgical procedure within 5 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEnsure Surgery Immunonutrition shake

Nutrition shake to support immune health and recovery from surgery.


Locations(1)

Columbia University Medical Center

New York, New York, United States

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NCT05655910


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