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NCT Number: NCT07655843

Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder

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

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Key information

About this study

Introduction

ADHD is a common and highly heritable neurodevelopmental disorder with an estimated worldwide prevalence of 3-7% in childhood and adolescence, and around 3% in adulthood . The prevalence of ADHD in the Middle East and North Africa region is estimated at approximately 10.3% among children, adolescents, and adults. The estimated prevalence was 12% in Egypt .

ADHD is characterized by developmentally inappropriate, pervasive and impairing inattention and/or hyperactivity-impulsivity. In addition to the core clinical symptoms of ADHD, co-occurring poor mental and physical comorbidities are prevalent in individuals with ADHD. However, compared with the extensive research of psychiatric comorbidities in ADHD, physical comorbidities, such as cardiovascular diseases , have received less attention, particularly among adults .

ADHD has a multifactorial etiology; however, its prevalence appears significantly higher in children with congestive heart disease, particularly those undergoing complex cardiac procedures such as aortic arch repair or correction of transposition of the great arteries . Children and adolescents with ADHD have a higher risk for cardiovascular disease. Common carotid intima media thickness , epicardial adipose tissue thickness , and periaortic adipose tissue thickness were higher in children and adolescents with ADHD, and therefore they were at risk for CVD .

A recent genetic study revealed weak-to-moderate genetic correlations of ADHD with BMI, coronary artery disease and levels of triglycerides and HDL cholesterol.

There are several reasons why individuals with ADHD could be at increased risk for CVDs. First, previous research suggests that the link between ADHD and CVDs is biologically plausible via immune system abnormalities, neuromodulator dysregulation, and dysregulation of the hypothalamic-pituitary-adrenal axis . Second, individuals with ADHD are at increased risk for unhealthy lifestyle factors (e.g., obesity, poor physical activity) which are all well-established risk factors for CVDs . Third, previous studies indicate that several psychiatric comorbidities of ADHD, for example, depression, substance use disorders, bipolar disorder, are associated with CVDs . Fourth, even though findings are inconclusive, there has been a long-standing concern around a potential increased risk of cardiovascular events due to the use of stimulant medications to treat ADHD. Most ADHD treatments are known to elevate heart rate and blood pressure through stimulation of the sympathetic nervous system, thus potentially conferring a risk of cardiovascular side-effects. Acute coronary syndromes, stroke, and heart failure have all been linked with treatment in some reports. However, the available epidemiological findings are mixed, despite the potential hypotheses for an increased risk of CVDs in ADHD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: within one week of emrollment

    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

  2. systolic blood pressure

    Time frame: within one week of enrollment

    Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups.

    Unit of Measure: Millimeters of mercury (mmHg)

  3. diastolic blood pressure

    Time frame: within one week of enrollment

    Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups.

    Unit of Measure: Millimeters of mercury (mmHg)

Secondary outcomes

  1. body mass index

    Time frame: within one week of enrollment

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Ahmed Allam, MBBCH

CONTACT

[email protected]

01063146513

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder Attending Assiut University Children Hospital: A Case Control Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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