Cross-sectional study of 24-hours blood pressure measures and left ventricular mass using echocardiograms in late adolescents and adults with ADHD.

Phase 4

Completed

• Conditions: Bloeddruk; Attention deficit disorder with hyperactivity; hyper active children; 10082206

• Registration Number: NL-OMON37801
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

Target group:
Patients with ADHD according to DSM-IV criteria (any subtype), based on clinical diagnosis, and confirmed by a structured interview [depending on local procedures: ADHD module of the K-SADS (Kaufman et al., 2000) or CAADID (Conners Adult ADHD Diagnostic Interview for DSM-IV) (www.mhs.com/) or DIVA (Diagnostic Interview for Adult ADHD) (www.divacenter.eu/Content/Downloads/DIVA_2.pdf).
• Aged between 15 and 25 years.
• Any comorbidity is allowed.
• Any comedication is allowed.
• Treated with methylphenidate (IR or ER preparations) for 3 years or longer, continuously.;Note: we will attempt to recruit at least 50% of the participants of the target group being treated continuously for 3 years with a minimum effective dose of 0.5 mg methylphenidate /kg/day). Being treated continuously means being prescribed methylphenidate continuously but may include the presence of drug holidays. We will measure adherence by asking questions about drug holidays and % of the overall dose taken. We will allow for some variation in dosages prescribed to be able to analyze dose-response relationships.;Control group:
• Patients with ADHD according to DSM*IV criteria (any subtype), based on clinical diagnosis.
• Aged between 15 and 25 years.
• Any comorbidity is allowed.
• Any comedication is allowed.
• Never been treated with methylphenidate.

Exclusion Criteria

All Groups: Treatment with dexamfetamine or atomoxetine.
ADHD controls: Treatment with methylphenidate.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Hypertension defined on the basis of 24*hour blood pressure measures as<br /><br>systolic and/or diastolic blood pressure of a positive value >= 1.65 (equivalent<br /><br>to the 95th percentile).<br /><br><br /><br>• Left ventricular mass will be indexed by a partition. A partition value will<br /><br>be taken at the 95th percentile of measurements indexed to body size (whether,<br /><br>height, weight or body surface area). This has the attraction of simplicity and<br /><br>will be used as the primary outcome measure. This method essentially<br /><br>categorises individuals into *normal* or *increased* left ventricular mass<br /><br>without conveying the degree to which the abnormal measurement differs from the<br /><br>reference population. LVM will be indexed to the allometric height in meters<br /><br>raised to the power of 2.7 (g/m2.7). This been extensively reported, with a<br /><br>value of 38.6g/m2.7 denoting the 95th percentile (de Simone et al 1992; de<br /><br>Simone et al 1995). </p><br>