[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536071":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":80,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":41,"enrollmentInfo":96,"targetDuration":41,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"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",[47,64,71],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Magee Women's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-79.99589,40.44062,{"lat":59,"lon":58},[62],{"name":34,"role":39,"phone":41,"phoneExt":41,"email":63},"saraf@pitt.edu",{"facility":65,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Presbyterian Hospital",{"type":56,"coordinates":67},[58,59],{"lat":59,"lon":58},[70],{"name":34,"role":39,"phone":41,"phoneExt":41,"email":63},{"facility":72,"status":49,"city":50,"state":51,"zip":73,"country":53,"countryCode":54,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Children's Hospital of Pittsburgh","15224",{"type":56,"coordinates":75},[58,59],{"lat":59,"lon":58},[78],{"name":79,"role":39,"phone":41,"phoneExt":41,"email":63},"Anita Saraf, MD,PhD",{"type":81,"investigatorFullName":82,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Anita Saraf",[84],{"name":85,"class":6},"The Pittsburgh Foundation","100536071","phase-4-efficacy-of-sodium-glucose-transporter-inhibitor-sglt2i-in-adult-patients-with-congenital-heart-disease-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":97,"type":98},40,"ESTIMATED","INTERVENTIONAL",[101],"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).",[104,105],"Adult Congenital Heart Disease","Heart Failure",[107,108,109],"congenital heart disease","reduced exercise capacity","decreased cardiac function","2025-10-02",{"date":112,"type":113},"2025-10-06","ACTUAL",{"date":115,"type":113},"2024-09-17",{"date":117,"type":98},"2027-06-01",{"name":82,"class":6},3]