Identification of the Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation at a Pharmacological and Physiological Stimulus in an Apparently Normal Population
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 997
- 试验地点
- 1
- 主要终点
- The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol.
研究概览
简要总结
The main objective is to research for genetic factors involved in the extreme modifications of the QT interval of the electrocardiogram in answer to a pharmacological stimulation (sotalol) and physiological stimulation in the apparently normal general population.
The phenotypic characterization, based on the ventricular repolarisation dynamics will be used aiming at term of the predictive genetic factors of the acquired long QT syndrome
详细描述
Study of 1000 apparently healthy subjects which will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes
- •Age between 18 and 60 years
- •European or North African Origin
- •Body mass index between 19 and 29 kg / m ²
- •Obtaining informed and written consent
排除标准
- •Heart rate < 50 bpm
- •Systolic blood pressure < 100 mm Hg
- •Atrioventricular block
- •Known chronic illness with chronic treatment
- •Raynaud phenomenon
- •QT prolonging drug
- •Family or personal history of the congenital long QT syndrome
- •QT/QTc Fridericia (QTcf) > 450 ms
- •Pregnancy
研究组 & 干预措施
1
Healthy subjects
干预措施: Sotalol 80 mg (Drug)
结局指标
主要结局
The elongation of the corrected interval QT duration 3 hours after the unique oral taking of an 80 mg dose of Sotalol.
时间窗: 3 hours after the taking of Sotalol
次要结局
- Look for associations between these phenotypes of electrocardiographically answer and mutations or polymorphisms.(At the inclusion visit)
- Constitute a biological base and a phenotypic base of resources which will allow to define answer phenotypes to the implemented dynamic tests(At the inclusion visit)