Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

NCT02302274 | Completed DMC FDA Drug

• 1 other identifier: 10-00253
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Brugada Syndrome; Arrhythmogenic Right Ventricular Cardiomyopathy

Keywords

Brugada Syndrome; ARVC; flecainide; ST elevation

Outcome Measures

Primary Outcomes (1)

• diagnosis

  conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG

  10 minutes

Secondary Outcomes (1)

• absence of arrhythmias elicited during the test

  10 minutes

Study Arms (1)

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

Interventions

flecainide iv DRUG

infusion over 10 min

flecainide infusion test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Type 1 Brugada Syndrome ECG
• Pregnancy
• History and/or evidence of ischemic cardiomyopathy
• Recent myocardial infarction
• Allergy or known adverse reaction to flecainide

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New york University, School of Medicine

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Brugada Syndrome; Arrhythmogenic Right Ventricular Dysplasia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiomyopathies; Congenital Abnormalities

Study Officials

• Steven Fowler, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: July 1, 2010
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)