Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- change in heart rate variability
研究概览
简要总结
The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis.
This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.
The fingolimod treatment is prescribed according to the accepted drug label.
详细描述
The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 years
- •Understands the proposed research and actions to be taken
- •The written informed consent has given
- •clinical indication to fingolimod-treatment
排除标准
- •Patient refuses
- •Patient takes or has taken part in other clinical drug trial during the last month
- •No clinical indication to the use of fingolimod
- •Contraindication to the use of fingolimod
结局指标
主要结局
change in heart rate variability
时间窗: prior medication vs initiation vs 3 month
次要结局
未报告次要终点