ADHD - Combined TypeNCT07655843
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder
An observational study of ADHD - Combined Type, run by Assiut University.
Trial summary
To identify the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Combined Type
- What is being tested?
- echocardiography and ECG
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
- -
Who cannot join
- Age > 18 years
- Patients who have a history of chronic diseases.
- Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder Attending Assiut University Children Hospital: A Case Control Study
To identify the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD
Read the 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.
- Conditions
- ADHD - Combined Type
- Being tested
- echocardiography and ECG
- Keywords
- cardiovascular abnormalities
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography and ECGDiagnostic test
- Electrocardiography (ECG): Twelve-lead ECG will be taken using 12A ECG device .
- Echocardiographic Measurements M-Mode echocardiographic measurements clinical history and examination
| Study group | Role | What they receive |
|---|---|---|
| case group | : consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment. Receives: Diagnostic Test: echocardiography and ECG | |
| control group | composed of age and sex matched neurotypical children Receives: Diagnostic Test: echocardiography and ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within one week of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Combined TypeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelrahman Ahmed Allam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655843
- Sponsor's protocol ID
- ADHD
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder Attending Assiut University Children Hospital: A Case Control Study
- ClinicalTrials.gov ID
- NCT07655843
- Acronym / sponsor ID
- ADHD
- Conditions
- ADHD - Combined Type
- Keywords
- cardiovascular abnormalities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: echocardiography and ECG: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment. |
| control group | – | Diagnostic Test: echocardiography and ECGcomposed of age and sex matched neurotypical children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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
- Healthy, typically developing children , matched by age and sex to the case group
Key exclusion criteria (3 listed)
- Age > 18 years
- Patients who have a history of chronic diseases.
- Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography and ECG* Electrocardiography (ECG): Twelve-lead ECG will be taken using 12A ECG device . * Echocardiographic Measurements M-Mode echocardiographic measurements clinical history and examination | Diagnostic test | case group, control group |
Primary outcome
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
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)
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)
1 secondary outcome
body mass index
Time frame: within one week of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD - Combined Type, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Ahmed Allam, MBBCH (01063146513, Ahmed.16266349@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of ECG and echocardiographic abnormalities in children with ADHD. (time frame: within one week of emrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.