Clinical Trial: Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomized Crossover Trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Vanderbilt University Medical Center

Current Primary Outcome: Ventricular Ectopy and VT During Exercise Treadmill Testing [ Time Frame: 3 months ]

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.


Original Primary Outcome: To assess the efficacy of flecainide in reducing cardiac events in CPVT [ Time Frame: 3 years ]

Hypothesis: the addition of oral flecainide to standard therapy will reduce cardiac events compared to placebo plus standard therapy, in patients with CPVT.

Cardiac event defined as: VT treated by ICD or death



Current Secondary Outcome:

Original Secondary Outcome:

  • To assess the efficacy of flecainide in reducing ventricular ectopy and VT during exercise treadmill testing in CPVT [ Time Frame: 3 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.
  • To correlate ventricular ectopy and VT during exercise treadmill testing with cardiac events in CPVT [ Time Frame: 3 years ]
    Hypothesis: the degree of ventricular ectopy and VT during exercise treadmill testing will correlate with cardiac events regardless of therapy in CPVT.


Information By: Vanderbilt University Medical Center

Dates:
Date Received: May 4, 2010
Date Started: December 2011
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017