Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Recurrence of syncope or presyncope and adverse events
研究概览
简要总结
Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.
详细描述
Several drugs which are commonly used in clinical practice, such as antihypertensive, antiarrhythmic and psychiatric drugs, are associated with orthostatic hypotension and syncope. This phenomenon is much more evident in the elderly and with multiple therapies. The present study was aimed to investigate, in patients affected by reflex syncope, the clinical effects (reduction in syncope recurrence and associated symptoms) and the laboratory tests (negativization of carotid sinus massage and tilt table test) when such drugs are discontinued or reduced
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients assuming chronic (>1 year) vasoactive therapy affected by reflex recurrent (>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage
排除标准
- •Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing
- •Competing diagnosis of syncope different from hypotensive reflex syncope
- •Reflex syncope with negative response to carotid sinus massage and tilt table test
- •Cardioinhibitory reflex syncope which requires permanent cardiac pacing
- •Severe hypertension which requires treatment (>150/95)
- •Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure
- •Cardiac hypotensive therapy in order to prevent recurrences
- •Previous stroke or transient ischemic attacks
研究组 & 干预措施
Stop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
干预措施: Stop/reduce vasoactive drugs (Other)
Vasoactive drug therapy
Continue current vasoactive therapy
干预措施: Vasoactive drug therapies (Drug)
结局指标
主要结局
Recurrence of syncope or presyncope and adverse events
时间窗: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events
次要结局
- Syncope(From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years)
- Presyncope(From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years)