[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563231":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":68,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":32,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Population specific PK model-derived digoxin dosing","EXPERIMENTAL","Digoxin elixir will be used to dose enterally every 12 hours.\n\nThe dosage will be determined by the protocol PK model. Dosing is to be administered based on weight, postnatal age, and estimated glomerular filtration rate\n\nThe duration of the participation could be up to 180 days. Day 1 to S2P or Day 180 (+\u002F- 7)",[13],"Drug: PK\u002FPD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","PK\u002FPD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease","Table 3: Digoxin dosing regimen based on optimized Cmin,ss Dose to be given twice daily (mcg\u002Fkg\u002Fdose) PNA\\\u003C30 days 30 days \\\u003C PNA \\\u003C 180 days eGFR≤40 1.4 1.4 40\\\u003CeGFR≤60 1.6 1.6 eGFR\\>60 1.9 2.8",[9],[21],"Lanoxin",[23],{"name":24,"affiliation":25,"role":26},"Christoph Hornik, MD","Duke Clinical Research Institute","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Alex Hammett, BS\u002FBA","CONTACT","919-668-8432",null,"Alex.Hammett@duke.edu",[35,53],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27701","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-78.89862,35.99403,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":32,"phoneExt":32,"email":52},"Elizabeth Thompson, MD","liz.thompson@duke.edu",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Medical University of South Carolina","NOT_YET_RECRUITING","Charleston","South Carolina","29425",{"type":44,"coordinates":60},[61,62],-79.93275,32.77632,{"lat":62,"lon":61},[65],{"name":66,"role":30,"phone":32,"phoneExt":32,"email":67},"Eric Graham, MD","grahamem@musc.edu",{"type":69,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[71,72,73],{"name":54,"class":6},{"name":25,"class":6},{"name":74,"class":75},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100563231","phase-1-pkpd-of-digoxin-in-infants-with-svhd-100563231",false,"NCT06613477","PK\u002FPD of Digoxin in Infants With SVHD","Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease","Digoxin R01","Inclusion Criteria:\n\n1. Diagnosis of single ventricle congenital heart disease\n2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation\n3. Age ≤ 30 days of life at time of stage 1 palliation\n4. Age \\\u003C 6 months at time of enrollment\n5. Require treatment with enteral digoxin per their treating medical provider\n6. Informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n1. Gestational age at birth \\\u003C35 weeks\n2. Serum creatinine \\> 2 mg\u002FdL at enrollment\n3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment\n4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment\n5. Known hypersensitivity to digoxin or other forms of digitalis\n6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment\n7. Received digoxin prior to enrollment\n8. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","30 Days","6 Months",{"count":88,"type":89},20,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","The primary participant will be an infant with single ventricle heart disease.\n\nThis is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function.\n\nThe investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care (\"opportunistic\"). The investigators will also collect information from medical records.\n\nBeing part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.",[96,97,98,99],"Single-ventricle","Infant Conditions","Infant, Newborn, Diseases","Infant, Premature, Diseases",[101,102,103,104,105,106,107,108,109],"Infants","SVD","SVHD","Single Ventricle","Digoxin","Pharmacokinetics","Pharmacodynamics","PK","PD","2026-01-28",{"date":112,"type":113},"2026-01-30","ACTUAL",{"date":115,"type":113},"2024-10-10",{"date":117,"type":89},"2026-11-30",{"name":5,"class":6},2]