[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606239":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dosing","EXPERIMENTAL","At the initial stage, investigators will allocate 3 subjects to 5 mg and 3 subjects 10 mg depending on their body weight (i.e., 5 mg for children with weight les than 40 kg, 10 mg for those with greater than 40 kg).",[13],"Drug: SGLT-2 inhibitor",{"label":15,"type":10,"description":16,"interventionNames":17},"Pharmacokinetics","In the second stage, based on the Pharmacokinetics (PK) analysis results from the initial 6 subjects divided in 5 mg and 10 mg dose groups, the next dose will be determined, for which the remaining 4 subjects will be allocated. The next dose decision will be made based on the target drug concentration levels along with the estimated PK parameters (e.g., the area under the drug concentration time curve and the maximum concentration), which correspond to adults PK and drug levels.",[18],"Drug: SGLT2 inhibitor",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SGLT-2 inhibitor","SGLT-2 inhibitor will be given once daily by mouth",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"SGLT2 inhibitor",[15],[30],{"name":31,"affiliation":32,"role":33},"Larry W. Markham, MD","Vanderbilt University Medical Center","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Larry W Markham, MD","CONTACT","615 322-7447","larry.w.markham@vumc.org",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Jennifer B Nicotera, RN","janet.b.nicotera@vumc.org",[44],{"facility":32,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.78444,36.16589,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Larry W. Markham","Professor of Pediatrics",[62],{"name":63,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100606239","phase-1-sodiumglucose-cotransporter-2-inhibitors-sglt2i-therapy-in-duchenne-cardiomyopathy-100606239",false,"NCT07172971","Sodium\u002FGlucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy","duCHennE caRdiomyopathy mItigation Sglt2 inHibitor","CHERISH","Inclusion Criteria:\n\n* Clinical phenotype of DMD confirmed with muscle biopsy or genotype\n* Presence of late gadolinium enhancement (LGE) imaging by CMR\n* Either normal or mildly depressed systolic function (LVEF\\>40%)\n* ≥8 years old and ≤18 years old\n\nExclusion Criteria:\n\n* Current investigational therapy that may affect cardiovascular function\n\n  * Additional genetic or congenital abnormality that may affect cardiovascular function or progression\n  * Contraindication to or inability to undergo CMR\n  * Symptomatic heart failure\n  * History of ketoacidosis or hypersensitivity to SGLT2i therapy\n  * Type 1 diabetes\n  * Renal disease or history of frequent urinary tract infections or genitourinary skin infections","MALE","8 Years","18 Years",{"count":77,"type":78},10,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","This is a pharmacokinetic study (PK Study) to better understand empagliflozin dosing in pediatric Duchenne muscular dystrophy patients. Empagliflozin is currently used off-label in this population due to the mortality benefits seen in adult cardiomyopathy and heart failure. Investigators will perform PK studies in DMD patients of various ages and weights to better understand the PK profile (absorption, distribution, metabolism, excretion) and dosing to better treat Duchenne cardiomyopathy.",[84],"Duchenne Muscular Dystrophy (DMD)",[86,87,88],"Cardiomyopathy","Heart failure","Muscular dystrophy","2026-06-29",{"date":91,"type":92},"2026-07-01","ACTUAL",{"date":91,"type":78},{"date":95,"type":78},"2028-02-01",{"name":59,"class":6},1]