Vascular Consequences of ADHD Medication Use in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Arterial stiffness
研究概览
简要总结
4.4 million children and adolescents in the United States have been diagnosed with attention deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS activation is closely associated with vascular functional and mechanical abnormalities. Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic profile, may have untoward effects on the vasculature and increase risk of developing cardiovascular disease in children and adolescents who use them.
Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents. We will address this objective by conducting a case-control study and obtain non-invasive measures of SNS activation, endothelial function, and arterial stiffness in children and adolescents (8-17 years old) with (using stimulant medication) and without ADHD.
详细描述
SPECIFIC AIMS AND HYPOTHESES
Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.
Our hypothesis is:
Children and adolescents taking ADHD medications will have higher SNS activation, lower digital reactive hyperemia, and higher pulse wave velocity and aortic augmentation index compared to sibling controls without ADHD.
Study Design We will obtain non-invasive measures of SNS activation (heart rate variability), endothelial function (digital reactive hyperemia and brachial artery flow-mediated dilation), and arterial stiffness (carotid-radial pulse wave velocity; aortic augmentation index) in youth taking ADHD stimulant medication and in their healthy siblings without ADHD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-18 years old
- •Current use of ADHD stimulant drug therapy limited to methylphenidates or amphetamines
- •Sibling without ADHD between the ages of 6-18 years old
排除标准
- •Known (diagnosed) cardiac disease
结局指标
主要结局
Arterial stiffness
时间窗: Baseline
Carotid-radial pulse wave velocity and aortic augmentation index.
次要结局
- SNS activation(Baseline)
- Endothelial Function(Baseline)