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Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder

13 juni 2026 bijgewerkt door: Ahmed Abdelrahman Ahmed Allam, Assiut University

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

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
case group
: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment.
  • Electrocardiography (ECG): Twelve-lead ECG will be taken using 12A ECG device .
  • Echocardiographic Measurements M-Mode echocardiographic measurements clinical history and examination
control group
composed of age and sex matched neurotypical children
  • Electrocardiography (ECG): Twelve-lead ECG will be taken using 12A ECG device .
  • Echocardiographic Measurements M-Mode echocardiographic measurements clinical history and examination

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
prevalence of ECG and echocardiographic abnormalities in children with ADHD.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
body mass index
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juni 2026

Primaire voltooiing (Geschat)

15 oktober 2027

Studie voltooiing (Geschat)

15 april 2028

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

13 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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