[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561421":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":24,"responsibleParty":42,"collaborators":45,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":88,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":24},{"fullName":5,"class":6},"Hannover Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard BP group","ACTIVE_COMPARATOR","The treatment goal for the standard group is to achieve BP levels \\\u003C90th pct.",[13],"Other: Standard Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Intensified BP group","EXPERIMENTAL","Treatment goal in the intensified group will be lowering BP ≤60th pct.",[19],"Other: Intensified BP control",[21,25],{"type":6,"name":22,"description":17,"armGroupLabels":23,"otherNames":24},"Intensified BP control",[15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Standard Treatment","Standard treatment is to achieve BP levels \\<90th pct.",[9],[30],{"name":31,"affiliation":5,"role":32},"Anette Melk, MD PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":31,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","+49 511 532 0","5597","sophocles@mh-hannover.de",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":38},"Bernhard MW Schmidt, MD MSc","2329",{"type":32,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Prof. Dr. Dr. Anette Melk","Professor of Pediatrics",[46,48,51,53,55,57,59,61,63],{"name":47,"class":6},"Heidelberg University",{"name":49,"class":50},"Berlin; Charité","UNKNOWN",{"name":52,"class":50},"Bonn; Kindernieren-zentrum Bonn",{"name":54,"class":6},"University Hospital, Essen",{"name":56,"class":50},"Frankfurt; Clementine Kinderhospital",{"name":58,"class":6},"Universitätsklinikum Hamburg-Eppendorf",{"name":60,"class":50},"Stuttgart; Olgahospital",{"name":62,"class":6},"Hacettepe University",{"name":64,"class":50},"Vienna; University Hospital Vienna","100561421","stopping-hypertension-and-improving-childrens-lives-after-kidney-transplantation-100561421",false,"NCT06589947","StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation","SOPHOCLES","Inclusion Criteria:\n\n* Kidney transplantation \\>12 months ago\n* Arterial hypertension\n\nExclusion Criteria:\n\n* Cardiac malformation\n* Treatment for a rejection episode within three months prior to inclusion","ALL","6 Years","18 Years",{"count":76,"type":77},170,"ESTIMATED","INTERVENTIONAL",[80],"NA","Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels \\\u003C75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients \\>12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target \\\u003C90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.",[83,84],"Arterial Hypertension","Kidney Transplant; Complications",[86,87],"Left ventricular mass","Pediatric kidney transplantation","NOT_YET_RECRUITING","2024-09-06",{"date":91,"type":92},"2024-09-19","ACTUAL",{"date":94,"type":77},"2024-09-16",{"date":96,"type":77},"2029-03",{"name":5,"class":6}]