N/A
N=14
Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
Catecholaminergic Polymorphic Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT01117454 ↗Enrolled (actual)
14
Serious AEs
15.4%
Results posted
May 2017
Primary outcome: Primary: Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing — 2; 9 Participants — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flecainide Acetate (Drug); Placebo (Drug); Beta blocker (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing |
2; 9 | 0.008 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01117454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.