Clinical trial of Flecainide for Catecholaminergic Ventricular Tachycardia

• Conditions: Patients with CPVT and ICD; MedDRA version: 14.1Level: LLTClassification code 10028159Term: Multiform ventricular tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001287-22-IT
• Lead Sponsor: FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of flecainide in reducing cardiac events in CPVT;Secondary Objective: - To assess the efficacy of flecainide in reducing ventricular ectopy and VT during exercise treadmill testing in CPVT - To correlate ventricular ectopy and VT during exercise treadmill testing with cardiac events in CPVT;Primary end point(s): VT treated by ICD or death;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18 months after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - VT leading to syncope but not treated by ICD; symptomatic VT not treated by ICD - exercise duration; peak heart rate during exercise test;Timepoint(s) of evaluation of this end point: 3, 6, 12, 18 months after treatment