Clinical Trial: Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Summary:
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:
- To demonstrate the higher sensitivity and specificity of flecainide iv infusion compared to procainamide infusion for the diagnosis of Brugada Syndrome.
- To demonstrate that flecainide is equally saf
Sponsor: New York University School of Medicine
Current Primary Outcome: diagnosis [ Time Frame: 10 minutes ]
conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG
Original Primary Outcome: Same as current
Current Secondary Outcome: safety: absence of arrhythmias elicited during the test [ Time Frame: 10 minutes ]
absence of arrhythmias elicited during the test
Original Secondary Outcome: Same as current
Information By: New York University School of Medicine
Dates:
Date Received: November 24, 2014
Date Started: July 2010
Date Completion: March 2018
Last Updated: March 20, 2017
Last Verified: March 2017
