Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
NCT ID: NCT01117454
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2011-12-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Flecainide then placebo
In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy with beta-blockers first, then crossover to placebo plus standard therapy with beta-blockers.
Flecainide Acetate
oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Placebo
placebo, similar in appearance to flecainide
Beta blocker
Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.
Placebo then flecainide
In this crossover study, half of the subjects will be randomized to placebo plus standard therapy with beta-blockers first, then crossover to flecainide plus standard therapy with beta-blockers.
Flecainide Acetate
oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Placebo
placebo, similar in appearance to flecainide
Beta blocker
Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.
Interventions
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Flecainide Acetate
oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
Placebo
placebo, similar in appearance to flecainide
Beta blocker
Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.
Eligibility Criteria
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Inclusion Criteria
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
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
5 Years
99 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Prince Joseph Kannankeril
Principal Investigator
Principal Investigators
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Prince J Kannankeril, MD, MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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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
Countries
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References
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Watanabe H, Chopra N, Laver D, Hwang HS, Davies SS, Roach DE, Duff HJ, Roden DM, Wilde AA, Knollmann BC. Flecainide prevents catecholaminergic polymorphic ventricular tachycardia in mice and humans. Nat Med. 2009 Apr;15(4):380-3. doi: 10.1038/nm.1942. Epub 2009 Mar 29.
van der Werf C, Kannankeril PJ, Sacher F, Krahn AD, Viskin S, Leenhardt A, Shimizu W, Sumitomo N, Fish FA, Bhuiyan ZA, Willems AR, van der Veen MJ, Watanabe H, Laborderie J, Haissaguerre M, Knollmann BC, Wilde AA. Flecainide therapy reduces exercise-induced ventricular arrhythmias in patients with catecholaminergic polymorphic ventricular tachycardia. J Am Coll Cardiol. 2011 May 31;57(22):2244-54. doi: 10.1016/j.jacc.2011.01.026.
Kannankeril PJ, Moore JP, Cerrone M, Priori SG, Kertesz NJ, Ro PS, Batra AS, Kaufman ES, Fairbrother DL, Saarel EV, Etheridge SP, Kanter RJ, Carboni MP, Dzurik MV, Fountain D, Chen H, Ely EW, Roden DM, Knollmann BC. Efficacy of Flecainide in the Treatment of Catecholaminergic Polymorphic Ventricular Tachycardia: A Randomized Clinical Trial. JAMA Cardiol. 2017 Jul 1;2(7):759-766. doi: 10.1001/jamacardio.2017.1320.
Related Links
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Full text of publication in JAMA Cardiology
Other Identifiers
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100472
Identifier Type: -
Identifier Source: org_study_id
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