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Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder

13. juni 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
prevalence of ECG and echocardiographic abnormalities in children with ADHD.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
body mass index
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

15. oktober 2027

Studiet fullført (Antatt)

15. april 2028

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

13. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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