[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658982":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":26,"overallOfficials":36,"centralContacts":41,"locations":26,"responsibleParty":47,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":26,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change in resting heart rate","Mean change in resting heart rate in beats per minute from baseline to 6 months.","At 6 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change in systolic blood pressure","Mean change in systolic blood pressure in mmHg from baseline to 6 months.",{"measure":18,"description":19,"timeFrame":12},"Change in diastolic blood pressure","Mean change in diastolic blood pressure in mmHg from baseline to 6 months.",{"measure":21,"description":22,"timeFrame":12},"Change in corrected QT interval","Mean change in corrected QT interval (QTc) in milliseconds from baseline to 6 months.",{"measure":24,"description":25,"timeFrame":12},"Proportion of children with cardiovascular adverse events","Proportion of children who experience cardiovascular adverse events such as palpitations or syncope during the study period.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","Atomoxetine is a selective norepinephrine reuptake inhibitor used in the treatment of ADHD. Because of its noradrenergic activity, it may affect cardiovascular parameters such as heart rate and blood pressure.\n\nThis observational study will include children aged 3 to 16 years with ADHD who will initiate atomoxetine therapy at enrollment. Resting heart rate, blood pressure, and electrocardiographic parameters will be assessed at baseline and at 6 months.","Children aged 3 to 16 years with attention-deficit\u002Fhyperactivity disorder who are planned to start atomoxetine therapy at Assiut University Children Hospital.",[33],{"label":34,"type":26,"description":35,"interventionNames":26},"Single cohort: Children with ADHD starting atomoxetine","Children aged 3 to 16 years with ADHD who will receive atomoxetine therapy and undergo cardiovascular assessment at baseline and at 6 months.",[37],{"name":38,"affiliation":39,"role":40},"Mohamed A Amir, prof","Pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Aya A Sayed, Resident","CONTACT","+20 11 47657483","ayaabdelwarith@gmail.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Aya Abdelwarith Sayed","Resident Physician, Department of Pediatrics","100658982","cardiovascular-safety-of-atomoxetine-in-children-with-adhd-100658982",false,"NCT07858448","Cardiovascular Safety of Atomoxetine in Children With ADHD","Cardiovascular Safety of Atomoxetine in Children With Attention-Deficit\u002FHyperactivity Disorder: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Children aged 3 to 16 years\n* Diagnosis of ADHD according to DSM-5 criteria\n* Planned initiation of atomoxetine therapy\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* Congenital heart disease\n* History of clinically significant cardiac arrhythmias\n* Hypertension\n* Known prolonged QT syndrome\n* Current treatment with medications affecting heart rate or QT interval\n* Previous atomoxetine treatment\n* Any clinically significant cardiovascular finding requiring specialist evaluation","ALL","3 Years","16 Years",{"count":62,"type":63},82,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study aims to evaluate the cardiovascular safety of atomoxetine therapy in children with attention-deficit\u002Fhyperactivity disorder during the first six months of treatment.",[67],"Attention Deficit Hyperactivity Disorder",[69,70,71,72,73,74],"Atomoxetine","Cardiovascular safety","ADHD","Heart rate","Blood pressure","Assiut","NOT_YET_RECRUITING","2026-09-29",{"date":78,"type":79},"2026-10-05","ACTUAL",{"date":81,"type":63},"2026-09-30",{"date":83,"type":63},"2028-02-01",{"name":5,"class":6}]