[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100262136":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":22,"locations":31,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with ASD or VSD and PAH",null,[12],"Other: Genetic testing",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":10},"Genetic testing","Genetic testing by DNA sequencing on blood samples after DNA extraction",[9],[19],{"name":20,"affiliation":5,"role":21},"Werner Budts, MD, PhD","PRINCIPAL_INVESTIGATOR",[23,27],{"name":20,"role":24,"phone":25,"phoneExt":10,"email":26},"CONTACT","+32 16 344369","werner.budts@uzleuven.be",{"name":28,"role":24,"phone":29,"phoneExt":10,"email":30},"Charlien Gabriels, MD","+32 16 341486","charlien.gabriels@uzleuven.be",[32],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University Hospitals Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.70093,50.87959,{"lat":43,"lon":42},[46,47,48],{"name":20,"role":24,"phone":25,"phoneExt":10,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":10,"email":30},{"name":28,"role":49,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":21,"investigatorFullName":51,"investigatorTitle":20,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"prof. dr. Werner Budts","100262136","genes-associated-with-development-of-pulmonary-arterial-hypertension-in-patients-with-congenital-shunt-lesions-100262136",false,"NCT02691689","Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Prospective, Monocentric Pilot Study for the Identification of Known or Novel Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Inclusion Criteria:\n\n* Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair\n* Development of PAH, defined as mean PAP ≥ 25 mmHg by right heart catheterization, in combination with a pulmonary wedge pressure of ≤ 15 mmHg and a PVR (pulmonary vascular resistance) of \\> 3 Wood units\n* Preferably, families with congenital shunt lesions (at least three family members affected with ASD or VSD) will be considered for inclusion\n\nExclusion Criteria:\n\n* Other congenital heart disease\n* Mental retardation\n* Dysmorphic characteristics\n* Chronic lung disease or total lung capacity \\\u003C 80% of predicted value\n* History of pulmonary embolism","ALL","18 Years",{"count":62,"type":63},21,"ESTIMATED","INTERVENTIONAL",[66],"NA","Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality.\n\nNext to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.",[69,70,71],"Heart Defects, Congenital","Pulmonary Arterial Hypertension","Genetic Testing","2026-04-27",{"date":74,"type":75},"2026-04-29","ACTUAL",{"date":77,"type":75},"2015-11",{"date":79,"type":63},"2027-02",{"name":5,"class":6},1]