跳至主要内容
临床试验/NCT07459478
NCT07459478招募中不适用

Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2025年10月30日最近更新:
适应症
干预措施

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

Experimental

干预措施: biofeedback and standard of care with tilt table testing (Diagnostic Test)

biofeedback and standard of care without tilt table testing

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frederik de Lange

Doctor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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