Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

Completed · Not applicable · Has a placebo group

Conditions studied: Catecholaminergic Polymorphic Ventricular Tachycardia

In brief

The purpose of this study is to test whether the addition of oral flecainide to standard therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.

Key facts

Study ID

NCT01117454

Run by

Vanderbilt University Medical Center

People needed

14

Starts

2011-12-01

Expected to finish

2015-12-01

Last updated by the study team

2017-06-14

Who can join

Age: 5 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of CPVT, based on:
• A. reproducible polymorphic or bidirectional ventricular tachycardia with exercise OR B. 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.

You may not qualify if…

• 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 A. Periodic paralysis or unexplained weakness B. Dysmorphic facies C. Known KCNJ2 mutation
• Patients with known hypersensitivity to flecainide
• Patients on amiodarone
• Patients not expected to comply with follow-up

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• NYU Langone Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Cook Children's Hospital — Fort Worth, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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