[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489652":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":28,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Dietary Supplement: Ensure Surgery Immunonutrition shake",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 1 (Not malnourished) - 1 product per day","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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 2 (at risk\u002Fmalnourished)","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.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIETARY_SUPPLEMENT","Ensure Surgery Immunonutrition shake","Nutrition shake to support immune health and recovery from surgery.",[15,9,19],null,[30],{"name":31,"affiliation":5,"role":32},"Melana Yuzefpolskaya, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","3472681454","my2249@cumc.columbia.edu",{"name":39,"role":35,"phone":40,"phoneExt":28,"email":41},"Annamaria Ladanyi, MD","3322177467","al4285@cumc.columbia.edu",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Columbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},[57,59,60,61,64,66,68],{"name":39,"role":35,"phone":58,"phoneExt":28,"email":41},"332-217-7467",{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"name":62,"role":63,"phone":28,"phoneExt":28,"email":28},"Paolo C Colombo, MD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":28,"phoneExt":28,"email":28},"Ryan T Demmer, PhD",{"name":67,"role":63,"phone":28,"phoneExt":28,"email":28},"Abigail Johnson, PhD, RDN",{"name":69,"role":63,"phone":28,"phoneExt":28,"email":28},"Jennifer Cho, RD",{"type":71,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[73],{"name":74,"class":75},"Abbott Nutrition","INDUSTRY","100489652","enhanced-nutritional-optimization-in-lvad-trial-100489652",false,"NCT05655910","Enhanced Nutritional Optimization in LVAD Trial","Enhanced Nutritional Optimization in LVAD (ENOL) Trial","ENOL","Inclusion Criteria:\n\n* age \\>18 years\n* hospitalized\n* undergoing LVAD therapy (enrolled at time of acceptance)\n\nExclusion Criteria:\n\n* intubated\n* congenital heart disease\n* infiltrative cardiomyopathy\n* unable to tolerate oral nutrition\n* surgery expected in \\\u003C5 days","ALL","18 Years",{"count":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91],"NA","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:\n\n* Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation?\n* 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.\n\nResearchers will compare malnourished participants drinking Ensure Surgery 3\u002Fday with well-nourished participants randomized to drink either 1\u002Fday or 3\u002Fday to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.",[94,95,96],"Heart Failure","Gut Microbiome","Nutritional Deficiency",[98,99,100,101,95],"Left Ventricular Assist Device (LVAD)","Advanced Heart Failure","Mechanical Circulatory Support","Infection","2025-10-30",{"date":104,"type":105},"2025-10-31","ACTUAL",{"date":107,"type":105},"2022-09-22",{"date":109,"type":88},"2027-01",{"name":5,"class":6},1]