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Trial record 1 of 200 for:    "Tachycardia, Ventricular" OR "catecholaminergic polymorphic ventricular tachycardia"
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Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

This study has been completed.
Information provided by (Responsible Party):
Prince Joseph Kannankeril, Vanderbilt University Identifier:
First received: May 4, 2010
Last updated: February 11, 2016
Last verified: February 2016
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.

Condition Intervention
Catecholaminergic Polymorphic Ventricular Tachycardia
Drug: flecainide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Crossover Trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • ventricular ectopy and VT during exercise treadmill testing [ Time Frame: 5 years ]
    Hypothesis: the addition of oral flecainide to standard therapy will reduce ventricular ectopy and/or VT on treadmill exercise treadmill testing in patients with CPVT, compared to placebo plus standard therapy.

Enrollment: 14
Study Start Date: December 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flecainide then placebo
In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.
Drug: flecainide
oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Placebo then flecainide
In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.
Drug: flecainide
oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml

Detailed Description:

Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a genetic arrhythmia syndrome characterized by frequent ventricular ectopy and polymorphic, classically bidirectional ventricular tachycardia with physical or emotional stress, which also carries a risk of ventricular fibrillation and sudden death, despite no structural heart abnormality. Treatment consists of beta-blockers and/or calcium channel blockers, but up to 30% of patients require implantable cardioverter-defibrillators (ICDs) due to recurrent symptoms on medical therapy. In an animal model, flecainide was found to directly target the molecular defect in CPVT. In a retrospective clinical study in patients with CPVT we have seen improvement of ventricular ectopy on exercise tests when flecainide is added to standard therapy. We propose a prospective trial of flecainide added to standard therapy in CPVT patients to test the hypothesis that flecainide will reduce ventricular ectopy on exercise testing compared to placebo plus standard therapy.

This will be a single-blind (blinded subjects) randomized cross-over study, in which each patient will receive treatment A (flecainide or placebo) for at least 3 months and, after a 1 week wash-out, treatment B (placebo or flecainide) for at least 3 months.


Ages Eligible for Study:   5 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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

  2. Functioning ICD in place
  3. 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.

Exclusion Criteria:

  1. Females who are pregnant or plan to be pregnant during the study period
  2. Children < 5 years of age
  3. Patients unable to perform treadmill exercise
  4. Patients with significant structural heart disease
  5. Patients with features consistent with Andersen-Tawil syndrome A. Periodic paralysis or unexplained weakness B. Dysmorphic facies C. Known KCNJ2 mutation
  6. Patients with known hypersensitivity to flecainide
  7. Patients on amiodarone
  8. Patients not expected to comply with follow-up
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Please refer to this study by its identifier: NCT01117454

United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10010
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37027
United States, Texas
Cook Children's Hospital
Fort Worth, Texas, United States, 76104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Prince J Kannankeril, MD, MSCI Vanderbilt University
  More Information

Responsible Party: Prince Joseph Kannankeril, Principal Investigator, Vanderbilt University Identifier: NCT01117454     History of Changes
Other Study ID Numbers: 100472
Study First Received: May 4, 2010
Last Updated: February 11, 2016

Keywords provided by Vanderbilt University:
Catecholaminergic Polymorphic Ventricular Tachycardia
implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017