Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Syncope recurrence rate
研究概览
简要总结
multicenter prospective randomized controlled comparison of biofeedback with tilt table testing (investigational management strategy) vs biofeedback without tilt table testing (reference management strategy) in patients with certain/highly likely vasovagal syncope
详细描述
Syncope is very common and has a broad differential diagnosis. The diagnosis reflex syncope, orthostatic hypotension, POTS or psychogenic syncope rely mainly on the initial syncope evaluation that consists of history taking, physical examination (including supine and standing blood pressure measurement) and ECG (class I, Level C). Besides the initial evaluation for the diagnosis also reassurance, explanation and education with biofeedback on life style measures is an important part of standard care and treatment of these patients (class 1, level B). In the current guidelines on syncope, provocation on tilt table testing should be considered in patients with suspected reflex syncope (Class IIb, Level B). For vasovagal syncope, which is a form of reflex syncope, tilt table testing has become a widely accepted tool in the work up and treatment, however evidence for this is lacking so far. In current medical practice there is a true equipoise for the use of provocation on tilt table in these patients. A randomized controlled trial to compare the standard of care without tilt table test versus standard of care with tilt table test in patients with certain/highly likely vasovagal syncope has never been done so far.
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
- •All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
排除标准
- •Those aged <18 years
- •Any patient diagnosed with another form of reflex syncope other than vasovagal syn-cope
- •Contraindication for tilt table testing at the discretion of the responsible physician
- •Those with a learning disability
- •Those presenting with pre-syncope and not with complete loss of consciousness
- •Those who are unwilling to provide informed consent
- •Those already diagnosed prior to evaluation who are referred for specific treatment op-tions
研究组 & 干预措施
biofeedback and standard of care with tilt table testing
干预措施: biofeedback and standard of care with tilt table testing (Diagnostic Test)
biofeedback and standard of care without tilt table testing
干预措施: no tilt table testing (Diagnostic Test)
结局指标
主要结局
Syncope recurrence rate
时间窗: From enrollment to the end of the follow-up at 12 months.
The rate of syncope recurrence
Time till first syncope
时间窗: Enrollment to 1 year after tilt-table test
Time till the first syncope after tilt-table testing
次要结局
- Near-syncope recurrence rate(Enrollment till 1 year after tilt table testing)
- Health Technology Assesment(Enrollment till 1 year after testing)
- Quality of life(Enrollment till 1 year after testing)
研究者
Frederik de Lange
Doctor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
