New NIH-Funded Clinical Trial for CPVT

If you have been diagnosed with catecholaminergic polymorphic ventricular tachycardia (CPVT)
and have an ICD, you may be eligible for a new clinical trial of flecainide, an antiarrhythmic drug
which may benefit patients with CPVT.

Study Basics
This is a trial of flecainide, an antiarrhythmic drug, for patients with Catecholaminergic
Polymorphic Ventricular Tachycardia (CPVT) who also have had an ICD implanted. The study is
being done to see if flecainide, when added to standard treatment, will reduce ICD shocks in
CPVT.


Who can be in this study?
Patients are eligible for the study if they:
  -Have a clinical diagnosis of CPVT based on the study enrollment criteria
  -Are older than 5 years of age
  -Have a functioning ICD in place
  -Are on stable doses of standard medicines
  -Can do an exercise treadmill test
  -Are NOT pregnant
  -Are NOT known to be allergic to flecainide
  -Are NOT taking amiodarone

Patients already on flecainide are eligible to enroll after stopping flecainide for at least 1 week
prior to entry.


How long will I be in the study?
Subjects will be in the study for just over 3 years.


What are the possible benefits for being in the study?
You may find out if flecainide will help reduce ICD shocks for you. Your participation will help
doctors learn if flecainide is good for patients with CPVT, and may lead to new discoveries
about genetic causes and modifiers of CPVT.


What are the possible risks for being in the study?
Possible risks of the study mainly come from the risks of flecainide. We will closely monitor you
for side effects during the study and will discuss what can be done to help or prevent them.


What are the costs for being in the study?
There will be no additional costs for being in this study. Tests required by the study that are not
a part of regular care will be provided free of charge. The study drug is provided free of charge.
You are responsible for all other costs related to your medical care such as hospitalization,
surgery, drugs, lab tests and physicians fees which are considered standard medical care.


Contact Information:
This study is being led by Dr. Prince Kannankeril, MD, MSCI, at Vanderbilt University Medical
Center. For questions or more information, email prince.kannankeril@vanderbilt.edu.
Additional information is available at http://clinicaltrials.gov/ct2/show/NCT01117454