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临床试验/EUCTR2011-001287-22-IT
EUCTR2011-001287-22-IT进行中(未招募)不适用

A Prospective Randomized Crossover trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE0 个研究点开始时间: 2012年3月5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)

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

  • - Clinical diagnosis of CPVT, based on: reproducible polymorphic or bidirectional ventricular tachycardia with exercise or Ventricular ectopy on exercise test with RYR2 or CASQ2 mutation - Functioning ICD in place - On stable dose of standard therapy defined as the maximal tolerated dose of beta-blocker and may include a calcium channel blocker (Patients on flecainide or mexiletine are also eligible for enrollment after a 1 week washout” period during which flecainide or mexiletine is discontinued, and standard therapy alone is used).
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 0
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Females who are pregnant or plan to be pregnant during the study period • Children < 5 years of age • Patients unable to perform treadmill exercise • Patients with significant structural heart disease • Patients with features consistent with Andersen-Tawil syndrome • Patients with known hypersensitivity to flecainide • Patients on amiodarone • Patients not expected to comply with follow-up

研究者

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