Pilot Randomized Trial With Flecainide in ARVC Patients
Status:
Recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder
with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter
defibrillator remains as therapy of choice. Antiarrhythmic therapy with different agents
including beta-blockers, sotalol and amiodarone are usually not effective in reducing risk of
arrhythmic events. Recent data indicated that flecainide effectively prevented the
arrhythmias observed in the experimental ARVC animals and in small series of ARVC patients.
These observations provide a strong rationale for conducting a pilot randomized clinical
trial to determine whether flecainide will reduce ventricular arrhythmias in high-risk ARVC
patients. This pilot study is designed as randomized double-blinded placebo-controlled
crossover trial with administration of 100 mg of Flecainide or matching placebo twice a day
for 4 weeks each with a washout period.
Primary specific aim of this pilot trial is to determine whether Flecainide administration is
associated with a significant reduction of number of ventricular ectopic beats (VEBs) in ARVC
patients with implantable cardioverter-defibrillator (ICD).