Health TrialsbyHealthPanel

Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder

ConditionADHD - Combined Type
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Age > 18 years

Patients who have a history of chronic diseases.

Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • echocardiography and ECG

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: case group1 intervention
Group B: control group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
within one week of emrollment
2

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)

Time frame
within one week of enrollment
3

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)

Time frame
within one week of enrollment

Secondary outcomes

1

body mass index

Anthropometric measurement to correlate nutritional/growth status with cardiac findings across the cohorts. Unit of Measure: Z-score (standard deviations from the mean based on WHO growth charts)

Time frame
within one week of enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: