[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541018":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":21,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Assessment Arm","EXPERIMENTAL","Assessment group will receive a single dose of oral sildenafil and oral pravastatin.",[13,14],"Drug: Sildenafil 10mg oral tablet (participants \u003C20kg), or 20mg oral tablet (participants ≥20kg)","Drug: Pravastatin 20 mg oral tablet (ages \u003C13 years), or 40 mg oral tablet (≥14 years)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Sildenafil 10mg oral tablet (participants \u003C20kg), or 20mg oral tablet (participants ≥20kg)","A single oral dose of sildenafil will be administered to all study subjects.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Pravastatin 20 mg oral tablet (ages \u003C13 years), or 40 mg oral tablet (≥14 years)","A single oral dose of pravastatin will be administered to all study subjects.",[9],[27],{"name":28,"affiliation":29,"role":30},"Jonathan Wagner, DO","Children's Mercy","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Jonthan Wagner, DO","CONTACT","816-731-7240","jbwagner@cmh.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Children's Mercy Hospital","RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-94.57857,39.09973,{"lat":50,"lon":49},[53,54],{"name":28,"role":34,"phone":21,"phoneExt":21,"email":21},{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"type":30,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Jon Wagner","Director, Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation",[59,61],{"name":60,"class":6},"Indiana Clinical and Translational Sciences Institute",{"name":62,"class":63},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100541018","phase-1-improving-drug-dosing-and-outcomes-for-single-ventricle-patients-with-fontan-associated-liver-disease-100541018",false,"NCT06324396","IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease","IMPROVE-FALD","Inclusion Criteria:\n\n* \\> 8 years\n* Status Post Fontan Completion\n* Ability to provide informed permission-assent (\\\u003C18 years) or consent (≥18 years)\n* Fasting overnight (\\~8 hours)\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-fasting\n* Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe\n* Sildenafil and\u002For Pravastatin therapy within last 2 months\n* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)\n* Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4\u002F5) inducers\u002Finhibitors) and\u002For Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers\u002Finhibitors)\n* Inability to swallow a tablet\n* \\>5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin\n* Diarrhea in the last 24 hours \\*History of solid organ transplantation","ALL","8 Years",{"count":74,"type":75},15,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.",[81],"Fontan Circulation",[83,84],"Fontan","FALD","2025-12-31",{"date":87,"type":88},"2026-01-02","ACTUAL",{"date":90,"type":88},"2024-03-01",{"date":92,"type":75},"2026-12-31",{"name":5,"class":6},1]