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Heart FailureENOLNCT05655910

Enhanced Nutritional Optimization in LVAD Trial

A study testing Ensure Surgery Immunonutrition shake in people with Heart Failure and Gut Microbiome, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ensure Surgery Immunonutrition shake
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
22 Sep 2022to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melana Yuzefpolskaya, MD contact

3472681454

my2249@cumc.columbia.edu

Annamaria Ladanyi, MD contact

3322177467

al4285@cumc.columbia.edu

United States1 site, 1 recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Annamaria Ladanyi, MD, 332-217-7467, al4285@cumc.columbia.edu

    Melana Yuzefpolskaya, MD, 3472681454, my2249@cumc.columbia.edu

    Recruiting

Other trials in United States

About this study

Official 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.

Read the detailed description

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.

Being tested
Ensure Surgery Immunonutrition shake
Keywords
Left Ventricular Assist Device (LVAD), Advanced Heart Failure, Mechanical Circulatory Support, Infection, Gut Microbiome
Medical subject headings
Heart Failure, Malnutrition, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ensure Surgery Immunonutrition shakeDietary supplement

    Nutrition shake to support immune health and recovery from surgery.

Study groups in NCT05655910
Study groupRoleWhat they receive
Group 1 (Not malnourished) - 3 products per dayExperimentalPatients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Receives: Dietary Supplement: Ensure Surgery Immunonutrition shake
Group 1 (Not malnourished) - 1 product per dayExperimentalPatients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 1 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Receives: Dietary Supplement: Ensure Surgery Immunonutrition shake
Group 2 (at risk/malnourished)ExperimentalPatients assessed as at risk for malnourishment or malnourished based on AND-ASPEN criteria automatically assigned to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Receives: Dietary Supplement: Ensure Surgery Immunonutrition shake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Day 5

  2. 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.

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  3. 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.

    Measured: Baseline and Discharge (approximately Day 25)

  4. 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.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

    Change in microbial gene count as measured in stool samples.

    Measured: Baseline and Day 5

  6. Change in Microbial Gene Count (Baseline and Pre-VAD)

    Change in microbial gene count as measured in stool samples.

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  7. Change in Microbial Gene Count (Baseline and Discharge)

    Change in microbial gene count as measured in stool samples.

    Measured: Baseline and Discharge (approximately Day 25)

  8. Change in Microbial Gene Count (Baseline and Post-Discharge Follow-up)

    Change in microbial gene count as measured in stool samples.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

    Change in biomarker CRP as measured in blood samples.

    Measured: Baseline and Day 5

  10. Change in C-Reactive Protein (CRP) (Baseline and Pre-VAD)

    Change in biomarker CRP as measured in blood samples.

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  11. Change in C-Reactive Protein (CRP) (Baseline and Discharge)

    Change in biomarker CRP as measured in blood samples.

    Measured: Baseline and Discharge (approximately Day 25)

  12. Change in C-Reactive Protein (CRP) (Baseline and Post-Discharge Follow-up)

    Change in biomarker CRP as measured in blood samples.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

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

    Measured: Baseline and Day 5

  14. Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Pre-VAD)

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

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  15. Change in N-terminal (NT)-pro hormone BNP (NT-proBNP) (Baseline and Discharge)

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

    Measured: Baseline and Discharge (approximately Day 25)

  16. 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.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

    Change in biomarker LPS as measured in blood samples.

    Measured: Baseline and Day 5

  18. Change in lipopolysaccharide (LPS) (Baseline and Pre-VAD)

    Change in biomarker LPS as measured in blood samples.

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

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

    Change in biomarker LPS as measured in blood samples.

    Measured: Baseline and Discharge (approximately Day 25)

  20. Change in lipopolysaccharide (LPS) (Baseline and Post-Discharge Follow-up)

    Change in biomarker LPS as measured in blood samples.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

    Change in biomarker TNF as measured in blood samples.

    Measured: Baseline and Day 5

  22. Change in Tumor Necrosis Factor (TNF) (Baseline and Pre-VAD)

    Change in biomarker TNF as measured in blood samples.

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  23. Change in Tumor Necrosis Factor (TNF) (Baseline and Discharge)

    Change in biomarker TNF as measured in blood samples.

    Measured: Baseline and Discharge (approximately Day 25)

  24. Change in Tumor Necrosis Factor (TNF) (Baseline and Post-Discharge Follow-up)

    Change in biomarker TNF as measured in blood samples.

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

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

    Measured: Baseline and Day 5

  26. Change in Interleukin 6 (IL-6) (Baseline and Pre-VAD)

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

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  27. Change in Interleukin 6 (IL-6) (Baseline and Discharge)

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

    Measured: Baseline and Discharge (approximately Day 25)

  28. Change in Interleukin 6 (IL-6) (Baseline and Post-Discharge Follow-up)

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

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

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

    Measured: Baseline and Day 5

  30. Change in Interleukin 10 (IL-10) (Baseline and Pre-VAD)

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

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  31. Change in Interleukin 10 (IL-10) (Baseline and Discharge)

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

    Measured: Baseline and Discharge (approximately Day 25)

  32. Change in Interleukin 10 (IL-10) (Baseline and Post-Discharge Follow-up)

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

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

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

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

    Measured: Baseline and Day 5

  34. Change in Short-Chain Fatty Acids (Baseline and Pre-VAD)

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

    Measured: Baseline and Pre-VAD (approximately Day 0-5)

  35. Change in Short-Chain Fatty Acids (Baseline and Discharge)

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

    Measured: Baseline and Discharge (approximately Day 25)

  36. Change in Short-Chain Fatty Acids (Baseline and Post-Discharge Follow-up)

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

    Measured: Baseline and Post-Discharge Follow-up (approximately Day 55)

Secondary outcomes (3)

  1. Post-LVAD Infections

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

    Measured: Day 25

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

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

    Measured: Day 25

  3. Post-LVAD Mortality

    Number of participant deaths.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start22 Sep 2022
  3. Primary completionOct 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three parallel comparison groups will be created based on assessment of nutritional status and randomization.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05655910
Sponsor's protocol ID
AAAT9591
Acronym
ENOL
Status last verified
Oct 2025
First submitted
9 Dec 2022
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

    PubMed 28785469

  • Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.

    PubMed 23989710

  • Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990 Nov;82(5):1724-9. doi: 10.1161/01.cir.82.5.1724.

    PubMed 2146040

  • Munger MA, Johnson B, Amber IJ, Callahan KS, Gilbert EM. Circulating concentrations of proinflammatory cytokines in mild or moderate heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 1996 Apr 1;77(9):723-7. doi: 10.1016/s0002-9149(97)89206-5.

    PubMed 8651123

  • Testa M, Yeh M, Lee P, Fanelli R, Loperfido F, Berman JW, LeJemtel TH. Circulating levels of cytokines and their endogenous modulators in patients with mild to severe congestive heart failure due to coronary artery disease or hypertension. J Am Coll Cardiol. 1996 Oct;28(4):964-71. doi: 10.1016/s0735-1097(96)00268-9.

    PubMed 8837575

  • Luedde M, Winkler T, Heinsen FA, Ruhlemann MC, Spehlmann ME, Bajrovic A, Lieb W, Franke A, Ott SJ, Frey N. Heart failure is associated with depletion of core intestinal microbiota. ESC Heart Fail. 2017 Aug;4(3):282-290. doi: 10.1002/ehf2.12155. Epub 2017 Apr 21.

    PubMed 28772054

  • Kummen M, Mayerhofer CCK, Vestad B, Broch K, Awoyemi A, Storm-Larsen C, Ueland T, Yndestad A, Hov JR, Troseid M. Gut Microbiota Signature in Heart Failure Defined From Profiling of 2 Independent Cohorts. J Am Coll Cardiol. 2018 Mar 13;71(10):1184-1186. doi: 10.1016/j.jacc.2017.12.057. No abstract available.

    PubMed 29519360

  • Sandek A, Bauditz J, Swidsinski A, Buhner S, Weber-Eibel J, von Haehling S, Schroedl W, Karhausen T, Doehner W, Rauchhaus M, Poole-Wilson P, Volk HD, Lochs H, Anker SD. Altered intestinal function in patients with chronic heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1561-9. doi: 10.1016/j.jacc.2007.07.016. Epub 2007 Oct 1.

    PubMed 17936155

  • Schorghuber M, Fruhwald S. Effects of enteral nutrition on gastrointestinal function in patients who are critically ill. Lancet Gastroenterol Hepatol. 2018 Apr;3(4):281-287. doi: 10.1016/S2468-1253(18)30036-0. Epub 2018 Mar 7.

    PubMed 29533200

  • Lin H, Zhang H, Lin Z, Li X, Kong X, Sun G. Review of nutritional screening and assessment tools and clinical outcomes in heart failure. Heart Fail Rev. 2016 Sep;21(5):549-65. doi: 10.1007/s10741-016-9540-0.

    PubMed 26920682

  • Al-Najjar Y, Clark AL. Predicting outcome in patients with left ventricular systolic chronic heart failure using a nutritional risk index. Am J Cardiol. 2012 May 1;109(9):1315-20. doi: 10.1016/j.amjcard.2011.12.026. Epub 2012 Feb 13.

    PubMed 22335857

  • Sze S, Zhang J, Pellicori P, Morgan D, Hoye A, Clark AL. Prognostic value of simple frailty and malnutrition screening tools in patients with acute heart failure due to left ventricular systolic dysfunction. Clin Res Cardiol. 2017 Jul;106(7):533-541. doi: 10.1007/s00392-017-1082-5. Epub 2017 Feb 15.

    PubMed 28204965

  • Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.

    PubMed 23099039

  • Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

    PubMed 31054241

  • Yuzefpolskaya M, Bohn B, Nasiri M, Zuver AM, Onat DD, Royzman EA, Nwokocha J, Mabasa M, Pinsino A, Brunjes D, Gaudig A, Clemons A, Trinh P, Stump S, Giddins MJ, Topkara VK, Garan AR, Takeda K, Takayama H, Naka Y, Farr MA, Nandakumar R, Uhlemann AC, Colombo PC, Demmer RT. Gut microbiota, endotoxemia, inflammation, and oxidative stress in patients with heart failure, left ventricular assist device, and transplant. J Heart Lung Transplant. 2020 Sep;39(9):880-890. doi: 10.1016/j.healun.2020.02.004. Epub 2020 Feb 13.

    PubMed 32139154

Questions about this trial

What is this clinical trial studying?

A study testing Ensure Surgery Immunonutrition shake in people with Heart Failure and Gut Microbiome, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melana Yuzefpolskaya, MD (3472681454, my2249@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alpha Diversity (Baseline and Day 5) (time frame: Baseline and Day 5). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05655910, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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Enhanced Nutritional Optimization in LVAD Trial | AzTrials