NCT07655843

Brief Summary

To identify the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Apr 2028

First Submitted

Initial submission to the registry

June 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 4, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

cardiovascular abnormalities

Outcome Measures

Primary Outcomes (3)

  • prevalence of ECG and echocardiographic abnormalities in children with ADHD.

    The percentage of children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) who exhibit one or more predefined structural or functional cardiac abnormalities on electrocardiogram (ECG) or transthoracic echocardiography (Echo). Abnormalities will be defined as: ECG Abnormalities: Prolonged corrected QT interval (QTc \> 450\\text{ ms} for males, \> 460\\text{ ms} for females using Bazett's formula), pathologic T-wave inversions, conduction blocks (e.g., right bundle branch block), or arrhythmias (e.g., ventricular premature beats). Echocardiographic Abnormalities: Left ventricular hypertrophy, structural congenital heart defects, valvular regurgitation (mitral/tricuspid) graded as moderate or severe, or reduced systolic function (Left Ventricular Ejection Fraction \< 55\\%). All assessments will be performed by a single blinded investigator using standard pediatric clinical guidelines to ensure consistency

    within one week of emrollment

  • systolic blood pressure

    Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups. Unit of Measure: Millimeters of mercury (mmHg)

    within one week of enrollment

  • diastolic blood pressure

    Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups. Unit of Measure: Millimeters of mercury (mmHg)

    within one week of enrollment

Secondary Outcomes (1)

  • body mass index

    within one week of enrollment

Study Arms (2)

case group

: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment.

Diagnostic Test: echocardiography and ECG

control group

composed of age and sex matched neurotypical children

Diagnostic Test: echocardiography and ECG

Interventions

* Electrocardiography (ECG): Twelve-lead ECG will be taken using 12A ECG device . * Echocardiographic Measurements M-Mode echocardiographic measurements clinical history and examination

case groupcontrol group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be divided into: * A case group: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment. * A control group: composed of age and sex matched neurotypical children.

You may qualify if:

  • Case group :
  • Age is \> 6 years and \<18 years old
  • Both sex
  • Patients diagnosed as having ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • Currently receiving pharmacological treatment for at least six months
  • Control group:
  • Healthy, typically developing children , matched by age and sex to the case group

You may not qualify if:

  • Age \> 18 years
  • Patients who have a history of chronic diseases.
  • Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

EchocardiographyElectrocardiography

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Central Study Contacts

Ahmed A Ahmed Allam, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 18, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

April 15, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share