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,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|