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NCT Number: NCT05655910

Enhanced Nutritional Optimization in LVAD 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Abigail Johnson, PhD, RDN

SUB_INVESTIGATOR

Annamaria Ladanyi, MD

CONTACT

[email protected]

332-217-7467

Jennifer Cho, RD

SUB_INVESTIGATOR

Melana Yuzefpolskaya, MD

CONTACT

[email protected]

3472681454

Melana Yuzefpolskaya, MD

PRINCIPAL_INVESTIGATOR

Paolo C Colombo, MD

SUB_INVESTIGATOR

Ryan T Demmer, PhD

SUB_INVESTIGATOR

About this study

Heart failure (HF) has an estimated prevalence of >37.7 million individuals globally. In the US alone, which is projected to increase by 46% between the years 2012 and 2030. Despite significant advances in HF medical and device therapies, patient prognosis after their first HF hospital admission is poor, with a <50% survival rate at five years and significant proportion of patients progressing from chronic stable disease to advanced HF state. Once advanced HF ensues, LVADs are one of the two main treatment modalities that can meaningfully improve survival in this patient population.

Chronic systemic inflammation is commonly observed in HF and is believed to be directly related to its pathogenesis. Recently, perturbations in the gut microbiota known as "gut dysbiosis" and impairment of gut mucosal barriers, facilitating entry of endotoxins and gut metabolites into the circulation, have also been observed in HF patients. Elevated levels of circulating endotoxins and bacterial bi-products enhance systemic inflammation, thereby contributing to progression of HF to more advanced disease state. Gut microbial perturbations may also alter enterocyte structure and function resulting in gastrointestinal dysmotility, nutrient malabsorption and eventually malnutrition.

Malnutrition is frequent in HF (as high as 62%), is associated with higher rates of mortality, hospital readmissions and an increased risk of adverse early postoperative outcomes. Infections are the most common complications following LVAD, affecting >50% of HF patients, contributing significantly to postoperative mortality, increased length-of stay (LOS) and hospital readmissions. The pre-operative period may represent an attractive time window in which to optimize HF patients, correct deficiencies, and enhance immune defense mechanisms before surgery. This period allows to act upon modifiable risk factors, such as the nutritional status, and potentially lower the risk of postoperative complications. However, the literature on perioperative optimization in HF comes mainly from anesthesiology and focuses on intra- and immediate postoperative management, when it may be too late to intervene and alter the outcome. Interestingly, guidelines on the nutritional evaluation and management of patients prior to non-cardiac surgery are available, but very limited literature is published concerning cardiac surgery, and no data exists with respect to LVAD surgery. The investigators plan to evaluation of the impact of preoperative nutrition intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ensure Surgery Immunonutrition shake

Dietary Supplement

Nutrition shake to support immune health and recovery from surgery.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Change in lipopolysaccharide (LPS) (Baseline and Day 5)

    Time frame: Baseline and Day 5

    Change in biomarker LPS as measured in blood samples.

  18. 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.

  19. Change in lipopolysaccharide (LPS) (Baseline and Discharge)

    Time frame: Baseline and Discharge (approximately Day 25)

    Change in biomarker LPS as measured in blood samples.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

Secondary outcomes

  1. Post-LVAD Infections

    Time frame: Day 25

    Number and type of infections experienced during index hospitalization following LVAD implantation

  2. Post-LVAD Length of Stay in intensive care unit

    Time frame: Day 25

    Number of days spent in intensive care unit following LVAD implantation.

  3. Post-LVAD Mortality

    Time frame: Up to 2 years

    Number of participant deaths.

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Ladanyi, MD

CONTACT

[email protected]

3322177467

Melana Yuzefpolskaya, MD

CONTACT

[email protected]

3472681454

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Abbott Nutrition

Registry information

Official study title

Enhanced Nutritional Optimization in LVAD (ENOL) Trial

Acronym: ENOL

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 19, 2022
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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