Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Brugada Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy
• Intervention / Treatment: Drug: 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
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
flecainide infusion test; 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.	Drug: flecainide iv; infusion over 10 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis	conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
absence of arrhythmias elicited during the test	number of arrhythmias caused by	10 minutes

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Steven Fowler, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: ST elevation; flecainide; ARVC; Brugada Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Cardiomyopathies; Brugada Syndrome; Arrhythmogenic Right Ventricular Dysplasia; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Flecainide
• Other Study ID Numbers: 10-00253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No