Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
Condition: Brugada Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy
MeSH terms: Cardiomyopathies; Brugada Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Syndrome
Study type: Observational

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).
    

Intervention name(s): flecainide iv
Intervention type(s): Drug
Intervention description(s): infusion over 10 min
Intervention MeSH terms: Flecainide
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients (age>18) who are seen in the Cardiovascular Genetics Program with a
        suspect diagnosis of Brugada Syndrome or with a suspect diagnosis of ARVC. This study will
        enroll adult individuals who are referred to the Center with a suspect of Brugada Syndrome
        or ARVC on the basis of uncertain ECG pattern, family history for sudden death syncope
        and/or cardiac arrest and/or ventricular arrhythmia in the absence of clear clinical
        markers for any other inherited cardiac disease.
      
Keywords: Brugada Syndrome; ARVC; flecainide; ST elevation