[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431831":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":24,"interventions":33,"overallOfficials":16,"centralContacts":39,"locations":49,"responsibleParty":71,"collaborators":16,"id":74,"slug":16,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":16,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":16,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":16,"overallStatus":52,"whyStopped":16,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluate effect of Liver Fat Percentage (on MRI) on AUC","We expect that increased liver adiposity will be associated with higher systemic statin exposure and thus, place those with higher liver adiposity fraction at increased risk for drug toxicity.","2 years",{"measure":14,"description":15,"timeFrame":12},"Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level","We expect that increased liver adiposity will be associated with an attenuated mevalonate response to a statin in obese children placing those with increased liver adiposity at risk for treatment failure.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"NON_RANDOMIZED","PARALLEL","This is a single center, open-label, prospective, investigation to quantify the effects hepatocellular fat has on hepatic statin transport (SA1) and response (SA2) in children and adolescents.","TREATMENT",{"masking":23,"maskingDescription":16,"whoMasked":16},"NONE",[25,28],{"label":26,"type":27,"description":16,"interventionNames":16},"Baseline Mevalonate and MRI Imaging","NO_INTERVENTION",{"label":29,"type":30,"description":16,"interventionNames":31},"Mevalonate Change After Rosuvastatin","EXPERIMENTAL",[32],"Drug: Rosuvastatin 10mg",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":16},"DRUG","Rosuvastatin 10mg","Rosuvastatin will be administered to all participants on Study Day #2",[29],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":16,"email":44},"Jonathan Wagner, DO","CONTACT","816-731-7240","jbwagner@cmh.edu",{"name":46,"role":42,"phone":47,"phoneExt":16,"email":48},"Jazzie K Holliday","816-302-3500","jkholliday@cmh.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Children's Mercy Hospital","RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-94.57857,39.09973,{"lat":62,"lon":61},[65,69],{"name":66,"role":42,"phone":67,"phoneExt":68,"email":44},"Jonathan B Wagner, DO","816-234-3000","59373",{"name":66,"role":70,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Jon Wagner","Principal Investigator","100431831",false,"NCT04903223","Liver Adiposity Effects on Pediatric Statin","Effects of Pediatric Liver Adiposity on Statin Disposition and Response","Inclusion Criteria:\n\n* 8-21 years\n* LDL cholesterol \\>130mg\u002Fdl (\\>95% percentile)\n* SLCO1B1 c.521TT genotype\n* Provide informed permission-assent(\\\u003C18 yrs.) or consent (≥18 yrs.)\n* Fasting overnight (\\~8 hrs.)\n* Enrolled in Cardiology Pharmacogenomic Repository\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-fasting\n* Non-removable metal in body or MRI unsafe\n* Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.\n* Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.\n* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\\* (absorption, metabolism, distribution, or clearance)\n* Pharmacotherapy that interacts with statins (OATP1B1 inducers\u002Finhibitors) \\*\n* Inability to swallow a tablet\n* \\>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin\n* Diarrhea in the last 24 hours\n* Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)",true,"ALL","8 Years","21 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin",[92],"Cholesterol; Lipidosis","2026-06-23",{"date":95,"type":96},"2026-06-25","ACTUAL",{"date":98,"type":96},"2021-04-01",{"date":100,"type":86},"2027-03-31",{"name":5,"class":6},1]