[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634093":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":10,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"National Cardiovascular Center Harapan Kita Hospital Indonesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulmonary Oligemia",null,"Patients with cyanotic CHD and univentricular physiology characterized by reduced pulmonary blood flow.",[13],"Procedure: Fontan Procedure",{"label":15,"type":10,"description":16,"interventionNames":17},"Pulmonary Plethora","Patients with cyanotic CHD and univentricular physiology characterized by increased pulmonary blood flow.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Fontan Procedure","Standard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Sisca Natalia Siagian, MD","CONTACT","+6281212716332","sisca.ped.car@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"National Cardiovascular Center Harapan Kita","RECRUITING","Jakarta","DKI Jakarta","11420","Indonesia","ID",{"type":40,"coordinates":41},"Point",[42,43],106.84513,-6.21462,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Sisca Natalia Siagian","Principal Investigator and Sponsor",[52,54,56],{"name":53,"class":6},"LMU Klinikum",{"name":55,"class":6},"Fakultas Kedokteran Universitas Indonesia",{"name":5,"class":6},"100634093","fontan-outcomes-in-oligemia-vs-plethora-in-univentricular-chd-100634093",false,"NCT07535203","Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD","Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure","Inclusion Criteria:\n\n* Diagnosed cyanotic CHD\n* Univentricular heart physiology\n* Planned staged palliation including Fontan procedure\n* Informed consent obtained (patient or guardian)\n\nExclusion Criteria:\n\n* Refusal to participate\n* Incomplete clinical data\n* Inability to complete follow-up","ALL",{"count":66,"type":67},52,"ESTIMATED","OBSERVATIONAL","This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.",[71,72],"Congenital Heart Disease (CHD)","Univentricular Heart",[74,75,76,77,78,79,80],"univentricular heart","congenital heart disease","fontan procedure","pulmonary blood flow","oligemia","plethora","pulmonary hemodynamics","2026-04-14",{"date":83,"type":84},"2026-04-17","ACTUAL",{"date":86,"type":84},"2025-01-01",{"date":88,"type":67},"2027-06",{"name":49,"class":6},1]