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Clinical Trials/EUCTR2011-001287-22-IT
EUCTR2011-001287-22-IT
Active, not recruiting
Not Applicable

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

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with CPVT and ICD
Sponsor
FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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