Diagnostic Value & Safety of Flecainide Infusion Test in Brugada Syndrome

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Arrhythmogenic Right Ventricular Cardiomyopathy
Arrhythmogenic Right Ventricular Dysplasia
Brugada Syndrome
Cardiomyopathies
Syndrome

Clinical Trial Details

NCT number	NCT02302274
Study type	Observational
Source	New York University School of Medicine
Contact
Status	Completed
Phase
Start date	July 1, 2010
Completion date	July 26, 2017

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms