[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564123":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":139,"collaborators":78,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":78,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":78,"enrollmentInfo":150,"targetDuration":78,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":96,"whyStopped":78,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin","EXPERIMENTAL","A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.",[13],"Drug: Empagliflozin",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],[24],"Jardiance",{"type":21,"name":15,"description":11,"armGroupLabels":26,"otherNames":27},[15],[28],"Control Group",[30],{"name":31,"affiliation":32,"role":33},"Josef Stehlik, MD MPH","VA Salt Lake City Health Care System, Salt Lake City, UT","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Heather Hanson, AAS BS","CONTACT","(801) 582-1565","4543","Heather.Hanson@va.gov",{"name":31,"role":37,"phone":38,"phoneExt":39,"email":42},"josef.stehlik@va.gov",[44,64,80,95,109,124],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"VA Palo Alto Health Care System, Palo Alto, CA","NOT_YET_RECRUITING","Palo Alto","California","94304-1207","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-122.14302,37.44188,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":62,"email":63},"Karim Sallam, MD","650-493-5000","61848","Karim.Sallam@va.gov",{"facility":65,"status":46,"city":66,"state":67,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Tennessee Valley Healthcare System Nashville Campus, Nashville, TN","Nashville","Tennessee","37212-2637",{"type":53,"coordinates":70},[71,72],-86.78444,36.16589,{"lat":72,"lon":71},[75],{"name":76,"role":37,"phone":77,"phoneExt":78,"email":79},"Henry Ooi, MD","615-327-4751",null,"henry.ooi@va.gov",{"facility":81,"status":46,"city":82,"state":83,"zip":84,"country":50,"countryCode":51,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","Texas","77030-4211",{"type":53,"coordinates":86},[87,88],-95.36327,29.76328,{"lat":88,"lon":87},[91],{"name":92,"role":37,"phone":93,"phoneExt":78,"email":94},"Savitri E Fedson, MD","713-791-1414","savitri.fedson@va.gov",{"facility":32,"status":96,"city":97,"state":98,"zip":99,"country":50,"countryCode":51,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"RECRUITING","Salt Lake City","Utah","84148-0001",{"type":53,"coordinates":101},[102,103],-111.89105,40.76078,{"lat":103,"lon":102},[106,108],{"name":36,"role":37,"phone":107,"phoneExt":39,"email":40},"801-582-1565",{"name":31,"role":33,"phone":78,"phoneExt":78,"email":78},{"facility":110,"status":46,"city":111,"state":112,"zip":113,"country":50,"countryCode":51,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Hunter Holmes McGuire VA Medical Center, Richmond, VA","Richmond","Virginia","23249-0001",{"type":53,"coordinates":115},[116,117],-77.46026,37.55376,{"lat":117,"lon":116},[120],{"name":121,"role":37,"phone":122,"phoneExt":78,"email":123},"Neil Lewis, MD","804-675-5000","neil.lewis@va.gov",{"facility":125,"status":46,"city":126,"state":127,"zip":128,"country":50,"countryCode":51,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":53,"coordinates":130},[131,132],-89.40123,43.07305,{"lat":132,"lon":131},[135],{"name":136,"role":37,"phone":137,"phoneExt":78,"email":138},"David R Murray, MD","608-256-1901","david.murray@va.gov",{"type":140,"investigatorFullName":78,"investigatorTitle":78,"investigatorAffiliation":78,"oldNameTitle":78,"oldOrganization":78},"SPONSOR","100564123","phase-4-randomized-trial-of-sglt2i-in-heart-transplant-recipients-100564123",false,"NCT06625073","Randomized Trial of SGLT2i in Heart Transplant Recipients","Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Heart transplant recipient, 3 months after transplant\n\nExclusion Criteria:\n\n1. eGFR \\\u003C20 mL\u002Fmin\u002F1.73m2\n2. Type 1 diabetes mellitus\n3. HbA1C \\>10%\n4. Baseline UACR \\\u003C30 mg\u002Fg in patients without T2D\n5. Known allergy or intolerance to SGLT2i\n6. Active uncontrolled infection\n7. Multiorgan transplant\n8. SGLT2i treatment in the last 30 days\n9. Pregnancy, breast-feeding or woman of child-bearing age not on birth control","ALL","18 Years",{"count":151,"type":152},200,"ESTIMATED","INTERVENTIONAL",[155],"PHASE4","Heart transplant (HTx) is an established therapy for advanced heart disease that restores quality of life and improves survival. However, due to preexisting comorbidities combined with the immunosuppressive therapies required after transplantation, HTx recipients remain at high risk for kidney, cardiovascular (CV), and metabolic disease. Large randomized clinical trials have recently shown that sodium-glucose cotransporter 2 inhibitors (SGLT2i) have potent kidney protective and CV benefits in many populations of patients with chronic kidney disease (CKD), CV disease and\u002For diabetes. SGLT2i have not been studied prospectively in HTx recipients, which represents a barrier to their use in this population.\n\nIn this multicenter randomized controlled trial in Veterans with HTx, investigators will evaluate the potential benefits of empagliflozin on kidney function, cardiometabolic risk, erythropoiesis, and functional status. A total of 200 Veterans will be randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo for 12 months.",[158,159,160],"Heart Transplant","Cardiovascular Disease","Kidney Disease",[158,9,162,163,164,165,166,167],"Safety and Tolerability","Kidney Outcomes","Cardiometabolic Outcomes","Erythropoiesis","Functional Status","Quality of Life","2026-01-21",{"date":170,"type":171},"2026-01-22","ACTUAL",{"date":173,"type":171},"2026-01-20",{"date":175,"type":152},"2030-02-28",{"name":5,"class":6},6]