Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Brief Title

Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Official Title

Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Brief Summary

      The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada
      Syndrome cases. It proposes to assess the safety profile of this test in US patients and its
      higher sensitivity when compared to procainamide infusion (the conventional drug used in the
      USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate
      if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.
    

Detailed Description

      Brugada Syndrome is an inherited arrhythmogenic disease responsible for life-threatening
      arrhythmias and sudden cardiac death in young individuals with structural normal heart.

      It is characterized by a peculiar ECG pattern, but this pattern could be intermittent. The
      infusion of sodium channel blockers (flecainide, ajmaline, procainamide) is used to unmask a
      concealed ECG pattern, thus providing an essential contribution to the diagnosis of this
      condition.

      In the current clinical practice in USA, only procainamide is used for diagnostic purposes;
      however in Europe only ajmaline and flecainide, available as iv formulations, are widely
      used. European and Japanese studies have demonstrated that the use of flecainide harbors less
      risks of adverse events in patients and may have a higher accuracy in unraveling the presence
      of the disease.

      In the present study the investigators propose to use flecainide infusion test in the
      Cardiovascular Genetics Program at NYUMC, in order to assess its sensitivity and specificity
      in diagnosing the disease and compare the incidence of adverse events to that observed during
      procainamide use.

      Additionally, the investigators propose to extend the study protocol to patients with a
      suspect diagnosis of Arrhythmogenic Right Ventricular Tachycardia (ARVC), due to the possible
      overlap between the two conditions.

      The study has the following aims:

        1. To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared
           to procainamide infusion for the diagnosis of Brugada Syndrome.

        2. To demonstrate that flecainide is equally safe or safer than procainamide to use for
           diagnosing Brugada Syndrome.

        3. To demonstrate that flecainide has high sensitivity and specificity in diagnosing also
           some patients with early stage Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).
    


Study Type

Observational


Primary Outcome

diagnosis

Secondary Outcome

 absence of arrhythmias elicited during the test

Condition

Brugada Syndrome

Intervention

flecainide iv

Study Arms / Comparison Groups

 flecainide infusion test
Description:  Patients with suspect Brugada Syndrome will be asked to undergo flecainide infusion (2 mg/Kg up to 150 mg maximum dose) over 10 minutes and their ECG will be continuously monitored. The objective of the study is to investigate if they show conversion from type 2 or type 3 ECG to a diagnostic type 1 ECG.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

209

Start Date

July 1, 2010

Completion Date

July 26, 2017

Primary Completion Date

July 26, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Suspect diagnosis of Brugada Syndrome or ARVC

          -  Idiopathic ventricular fibrillation and suspect concealed Brugada syndrome

          -  Family history of Brugada Syndrome

          -  Family history of unexpected cardiac sudden death

        Exclusion Criteria:

          -  Type 1 Brugada Syndrome ECG

          -  Pregnancy

          -  History and/or evidence of ischemic cardiomyopathy

          -  Recent myocardial infarction

          -  Allergy or known adverse reaction to flecainide
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Steven Fowler, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02302274

Organization ID

10-00253


Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Steven Fowler, MD, Principal Investigator, NYU School of Medicine


Verification Date

April 2019