Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Completed

• Conditions: Brugada Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy
• Interventions: Drug: flecainide iv

• Registration Number: NCT02302274
• Lead Sponsor: NYU Langone Health

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07-01
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Primary Completion: 2017-07-26
• Study Completion: 2017-07-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
flecainide infusion test	flecainide iv	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.

Primary Outcome Measures

Name	Time	Method
diagnosis	10 minutes	conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG

Secondary Outcome Measures

Name	Time	Method
absence of arrhythmias elicited during the test	10 minutes	number of arrhythmias caused by

Trial Locations

Locations (1)

New york University, School of Medicine; 🇺🇸 New York, New York, United States