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临床试验/EUCTR2013-004919-43-IT
EUCTR2013-004919-43-IT进行中(未招募)不适用

Suspension of vasoactive drugs in reflex vasodepressive syncope: a randomized controlled trial

SOD Medicina e Cardiologia Geriatrica, Centro per lo Studio della Sincope - Università degli Studi di Firenze-AOUCareggi0 个研究点开始时间: 2014年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients on chronic therapy (> 1 year) with vasoactive drugs with recurrent reflex syncope (= 2 episodes / last year), for who it has been demonstrated positive tilt test or has been diagnosed with carotid sinus syndrome with predominantly vasodepressor component (form vasodepressor or mixed).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • 1 - Patients with a diagnosis of symptomatic orthostatic hypotension, defined as a reduction in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg during the first 3 minutes after orthostatism.
  • 2 - Patients with a diagnosis of syncope different from the vasodepressor reflex syncope
  • 3 - Patients with reflex syncope with negativity of both carotid sinus massage and tilt test
  • 4 - Patients with a clinical diagnosis of reflex syncope with cardioinihibiting component that requires pacemaker implantation
  • 5 - Patients with poorly controlled hypertension (> 150/95)
  • 6 - Patients with heart failure in the suspension / reduction therapy carries the risk of worsening the heart failure
  • 7 - Patients with cardiac arrhythmias in which the suspension / reduction of antiarrhythmic therapy carries the risk of worsening arrhythmias
  • 8 - Patients with prior TIA or stroke.

研究者

发起方
SOD Medicina e Cardiologia Geriatrica, Centro per lo Studio della Sincope - Università degli Studi di Firenze-AOUCareggi

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