Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 5 - 99 |
Updated: | 4/21/2016 |
Start Date: | December 2011 |
End Date: | December 2015 |
A Prospective Randomized Crossover Trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
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.
therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard
therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.
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.
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.
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
We found this trial at
10
sites
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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University of Utah Research is a major component in the life of the U benefiting...
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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