[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536071":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":79,"collaborators":82,"id":85,"slug":41,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":41,"enrollmentInfo":94,"targetDuration":41,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin 10 MG","EXPERIMENTAL","Empagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.",[13],"Drug: Empagliflozin 10 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo for 1 year",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year",[9],[26],"Jardiance, Empagliflozin",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"To patients randomized to the placebo group, a placebo pill will be given",[15],[31],"Placebo Drug",[33],{"name":34,"affiliation":35,"role":36},"Anita Saraf, MD, PhD","Assistant Professor","PRINCIPAL_INVESTIGATOR",[38,43],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","4128648661",null,"sarafap@upmc.edu",{"name":44,"role":39,"phone":41,"phoneExt":41,"email":45},"Morgan Hindes","mhindes@chp.edu",[47,63,70],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Magee Women's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213","United States",{"type":55,"coordinates":56},"Point",[57,58],-79.99589,40.44062,{"lat":58,"lon":57},[61],{"name":34,"role":39,"phone":41,"phoneExt":41,"email":62},"saraf@pitt.edu",{"facility":64,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Presbyterian Hospital",{"type":55,"coordinates":66},[57,58],{"lat":58,"lon":57},[69],{"name":34,"role":39,"phone":41,"phoneExt":41,"email":62},{"facility":71,"status":49,"city":50,"state":51,"zip":72,"country":53,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Children's Hospital of Pittsburgh","15224",{"type":55,"coordinates":74},[57,58],{"lat":58,"lon":57},[77],{"name":78,"role":39,"phone":41,"phoneExt":41,"email":62},"Anita Saraf, MD,PhD",{"type":80,"investigatorFullName":81,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Anita Saraf",[83],{"name":84,"class":6},"The Pittsburgh Foundation","100536071",false,"NCT06260059","Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease","Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease","EmpaCHD","Inclusion Criteria:\n\n* Diagnoses of Congenital Heart Disease\n* Age 18+\n* ACHD level of structural complexity II or III\n* Recent (\\\u003C6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \\\u003C 60%\n* Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \\> 5% in the last 6 months or less.\n* Must be able to complete neurocognitive assessments on a handheld computer.\n\nExclusion Criteria:\n\n* Diagnosed with Diabetes\n* Contraindication to Jardiance\u002FEntresto or any heart failure medication (per guideline-directed therapy, 2022).\n* Previous therapy with Jardiance at \\\u003C4 weeks\n* Glomerular Filtration Rate \\\u003C20\n* Pregnancy, breastfeeding, or planning to become pregnant in the coming year\n* History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis\n* History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1)\n* Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,\n* Gaucher disease,\n* Tay-Sachs disease,\n* Mucolipidosis IV,\n* Niemann-Pick disease,\n* Type A mitochondrial disease,\n* Metabolic disorders related to glucose metabolism","ALL","18 Years",{"count":95,"type":96},40,"ESTIMATED","INTERVENTIONAL",[99],"PHASE4","The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).",[102,103],"Adult Congenital Heart Disease","Heart Failure",[105,106,107],"congenital heart disease","reduced exercise capacity","decreased cardiac function","2025-10-02",{"date":110,"type":111},"2025-10-06","ACTUAL",{"date":113,"type":111},"2024-09-17",{"date":115,"type":96},"2027-06-01",{"name":81,"class":6},3]