Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- HUTT positivity rate during passive phase
研究概览
简要总结
The purpose of the study is to compare the positivity rate associated with a novel simplified Tilt-Table (TT) test protocol versus the conventional TT protocol
详细描述
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) will be randomized to "conventional" HUTT protocol or "fast" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms NTG sublingual spray. The novel simplified "fast" HUTT protocol has been designed to provide non inferior positivity rates as compared with the conventional protocol in the selected population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with unexplained syncope at initial evaluation and indication to perform HUTT
排除标准
- •No informed consent
- •PM/ICD device recipients
研究组 & 干预措施
Conventional HUTT
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) randomized to "conventional" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; aprovocation phase of further 10 min after 300 micrograms NTG sublingual spray.
干预措施: Conventional HUTT (Diagnostic Test)
Fast HUTT
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) randomized to "fast" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms NTG sublingual spray.
干预措施: Fast HUTT (Diagnostic Test)
结局指标
主要结局
HUTT positivity rate during passive phase
时间窗: through study completion, an average of 1 year
The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.
HUTT positivity rate during active phase
时间窗: through study completion, an average of 1 year
The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.
次要结局
- The type of HUTT-induced syncope during passive phase(through study completion, an average of 1 year)
- The type of HUTT-induced syncope during active phase(through study completion, an average of 1 year)
研究者
Vincenzo Russo
Principal Investigator
University of Campania "Luigi Vanvitelli"