- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655843
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder Attending Assiut University Children Hospital: A Case Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed A Ahmed Allam, MBBCH
- Phone Number: 01063146513
- Email: Ahmed.16266349@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
-
Exclusion Criteria:
- Age > 18 years
- Patients who have a history of chronic diseases.
- Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
case group
: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment.
|
|
|
control group
composed of age and sex matched neurotypical children
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
within one week of emrollment
|
|
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) |
within one week of enrollment
|
|
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) |
within one week of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
within one week of enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Congenital Abnormalities
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Cardiovascular Abnormalities
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Electrodiagnosis
- Cardiac Imaging Techniques
- Ultrasonography
- Electrocardiography
- Echocardiography
Other Study ID Numbers
- ADHD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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