Enhanced Nutritional Optimization in LVAD Trial

NCT05655910 | Recruiting

• 1 other identifier: AAAT9591
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Gut Microbiome; Nutritional Deficiency

Keywords

Left Ventricular Assist Device (LVAD); Advanced Heart Failure; Mechanical Circulatory Support; Infection; Gut Microbiome

Outcome Measures

Primary Outcomes (36)

• 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

• 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)

• 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)

• 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)

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

  Change in microbial gene count as measured in stool samples.

  Baseline and Day 5

• 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)

• Change in Microbial Gene Count (Baseline and Discharge)

  Change in microbial gene count as measured in stool samples.

  Baseline and Discharge (approximately Day 25)

• 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)

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

  Change in biomarker CRP as measured in blood samples.

  Baseline and Day 5

• 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)

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

  Change in biomarker CRP as measured in blood samples.

  Baseline and Discharge (approximately Day 25)

• 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)

• 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

• 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)

• 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)

• 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)

• Change in lipopolysaccharide (LPS) (Baseline and Day 5)

  Change in biomarker LPS as measured in blood samples.

  Baseline and Day 5

• 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)

• Change in lipopolysaccharide (LPS) (Baseline and Discharge)

  Change in biomarker LPS as measured in blood samples.

  Baseline and Discharge (approximately Day 25)

• 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)

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

  Change in biomarker TNF as measured in blood samples.

  Baseline and Day 5

• 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)

• Change in Tumor Necrosis Factor (TNF) (Baseline and Discharge)

  Change in biomarker TNF as measured in blood samples.

  Baseline and Discharge (approximately Day 25)

• 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)

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

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

  Baseline and Day 5

• 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)

• 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)

• 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)

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

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

  Baseline and Day 5

• 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)

• 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)

• 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)

• 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

• 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)

• 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)

• 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 Outcomes (3)

• Post-LVAD Infections

  Day 25

• Post-LVAD Length of Stay in intensive care unit

  Day 25

• Post-LVAD Mortality

  Up to 2 years

Study Arms (3)

Group 1 (Not malnourished) - 3 products per day

EXPERIMENTAL

Patients 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.

Dietary Supplement: Ensure Surgery Immunonutrition shake

Group 1 (Not malnourished) - 1 product per day

EXPERIMENTAL

Patients 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.

Dietary Supplement: Ensure Surgery Immunonutrition shake

Group 2 (at risk/malnourished)

EXPERIMENTAL

Patients 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.

Dietary Supplement: Ensure Surgery Immunonutrition shake

Interventions

Ensure Surgery Immunonutrition shake DIETARY_SUPPLEMENT

Nutrition shake to support immune health and recovery from surgery.

Group 1 (Not malnourished) - 1 product per day; Group 1 (Not malnourished) - 3 products per day; Group 2 (at risk/malnourished)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Abbott Nutrition: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 28785469 BACKGROUND

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

  PMID: 23989710 BACKGROUND

• 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.

  PMID: 2146040 BACKGROUND

• 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.

  PMID: 8651123 BACKGROUND

• 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.

  PMID: 8837575 BACKGROUND

• 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.

  PMID: 28772054 BACKGROUND

• 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.

  PMID: 29519360 BACKGROUND

• 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.

  PMID: 17936155 BACKGROUND

• 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.

  PMID: 29533200 BACKGROUND

• 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.

  PMID: 26920682 BACKGROUND

• 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.

  PMID: 22335857 BACKGROUND

• 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.

  PMID: 28204965 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

• 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.

  PMID: 31054241 BACKGROUND

• 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.

  PMID: 32139154 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Malnutrition; Infections

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Melana Yuzefpolskaya, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melana Yuzefpolskaya, MD

CONTACT

3472681454; my2249@cumc.columbia.edu

Annamaria Ladanyi, MD

CONTACT

3322177467; al4285@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel comparison groups will be created based on assessment of nutritional status and randomization.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)