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Trial record 3 of 19 for:    Brugada Syndrome 1

Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome

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ClinicalTrials.gov Identifier: NCT02302274
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Brugada Syndrome Arrhythmogenic Right Ventricular Cardiomyopathy 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).

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome
Study Start Date : July 1, 2010
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : July 26, 2017


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




Primary Outcome Measures :
  1. diagnosis [ Time Frame: 10 minutes ]
    conversion from type 2/3 Brugada ECG to diagnostic type 1 ECG


Secondary Outcome Measures :
  1. absence of arrhythmias elicited during the test [ Time Frame: 10 minutes ]
    number of arrhythmias caused by



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302274


Locations
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United States, New York
New york University, School of Medicine
New York, New York, United States, 10010
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Steven Fowler, MD NYU School of Medicine

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02302274     History of Changes
Other Study ID Numbers: 10-00253
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Brugada Syndrome
ARVC
flecainide
ST elevation
Additional relevant MeSH terms:
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Brugada Syndrome
Syndrome
Cardiomyopathies
Arrhythmogenic Right Ventricular Dysplasia
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Genetic Diseases, Inborn
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action