AUTONOMIC DYSFUNCTION IN CHILDREN AND ADOLESCENTS TREATED FOR HYPOTHYROIDISM
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean difference in heart rate variability of cases and controls.
研究概览
简要总结
The autonomic nervous system controls the heart through complex interactions between sympathetic and parasympathetic divisions, producing fluctuations in heartbeat intervals. The greater the fluctuations in the beat-to-beat interval, the better the cardiovascular system functions to adapt and respond to internal and external stimuli.
Heart rate variability analysis is a sensitive measure of autonomic dysfunctions manifested as sympathovagal imbalance in humans. It is a non-invasive, widely applied method for cardiac autonomic assessment, and has been proposed as a marker for cardiovascular disease.
Earlier studies in adults have shown the autonomic dysfunction such as difference in HRV and heart rate in newly diagnosed patients with hypothyroidism as compared to controls. A few studies have compared pre-treatment vs post treatment dysautonomia in hypothyroidism to document partial improvement in ANS on treatment with levo-thyroxine.
It is postulated that this dysautonomia will normalize on continued therapy with levothyroxine. At present, satisfactory control of disease is considered when euthyroidism is achieved in the absence of any clinical features of hypothyroidism or hyperthyroidism. However, there are no studies that have evaluated status of ANS function in children treated for hypothyroidism.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 8.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Case: Children of age group 8- 18 years with primary hypothyroidism maintaining euthyroid status on L-thyroxine therapy for at least 6 months.
- •Controls: Age and gender matched apparently healthy children who are euthyroid of age group 8-18 years.
排除标准
- •Undergoing structured physical activity regime over last 3 months.
- •Fever or systemic illness requiring hospitalization in preceding 4 weeks.
- •Previously diagnosed hypertension, renal disease or cardiovascular disease.
- •On any drug which might affect heart rate like beta blockers/ agonists/ calcium channel blockers.
结局指标
主要结局
Mean difference in heart rate variability of cases and controls.
时间窗: Baseline
次要结局
- Mean difference in beat-to-beat variability in cases and controls.(Association of sleep/wake cycle with Continuous Ambulatory Blood Pressure Monitoring in cases.)
研究者
Dr Rahul Choudhary
Maulana Azad Medical College