Cardiovascular Safety of Atomoxetine in Children With ADHD

NCT07858448 — Not yet recruiting, 82 participants, Assiut University

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Cardiovascular Safety of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder: A Prospective Observational Cohort Study

Registry	NCT07858448
Status	Not yet recruiting
Study type	Observational
Enrollment	82 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Attention Deficit Hyperactivity Disorder
Dates	start 2026-09-30 (estimated), primary completion 2027-09-30 (estimated), completion 2028-02-01 (estimated), first posted 2026-10-05, last updated 2026-10-05

-Summary

This prospective observational cohort study aims to evaluate the cardiovascular safety of atomoxetine therapy in children with attention-deficit/hyperactivity disorder during the first six months of treatment.

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+Detailed description

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.

This 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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Change in resting heart rate [At 6 months]: Mean change in resting heart rate in beats per minute from baseline to 6 months.

Secondary outcomes

Change in systolic blood pressure [At 6 months]: Mean change in systolic blood pressure in mmHg from baseline to 6 months.
Change in diastolic blood pressure [At 6 months]: Mean change in diastolic blood pressure in mmHg from baseline to 6 months.
Change in corrected QT interval [At 6 months]: Mean change in corrected QT interval (QTc) in milliseconds from baseline to 6 months.
Proportion of children with cardiovascular adverse events [At 6 months]: Proportion of children who experience cardiovascular adverse events such as palpitations or syncope during the study period.

+Eligibility

Sex: All, ages: 3 Years to 16 Years

Inclusion Criteria:

* Children aged 3 to 16 years
* Diagnosis of ADHD according to DSM-5 criteria
* Planned initiation of atomoxetine therapy
* Written informed consent from parents or legal guardians

Exclusion Criteria:

* Congenital heart disease
* History of clinically significant cardiac arrhythmias
* Hypertension
* Known prolonged QT syndrome
* Current treatment with medications affecting heart rate or QT interval
* Previous atomoxetine treatment
* Any clinically significant cardiovascular finding requiring specialist evaluation

+Investigators

Mohamed A Amir, prof, Study chair, Pediatrics Department, Assiut University Hospitals