Empiric Quinidine for Asymptomatic Brugada Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine if quinidine therapy (not guided by the results of electrophysiologic studies) will reduce the long-term risk of arrhythmic events in asymptomatic Brugada Syndrome.

Official Title
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A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: quinidine
* Drug: no therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Asymptomatic Brugada syndrome. Brugada syndrome is defined as the presence of a Type-I Brugada electrocardiogram [coved ST-segment elevation ≥2 mm (0.2 mV) in V1, V2 or V3] either spontaneously (at rest, in the baseline state or during a febrile episode) or following a standard drug-challenge test (with flecainide, ajmaline, procainamide, or pilsicainide) and recorded either with standard electrode position or with the precordial electrodes placed on the second or third intercostal space. Negative T waves in the precordial leads are not required to define a Type I electrocardiogram. Asymptomatic patients will be defined as patients without a history of cardiac arrest, a history of arrhythmic syncope or a history of suspected arrhythmic syncope. Arrhythmic syncope is a syncope occurring during documented ventricular tachyarrhythmias. Suspected arrhythmic syncope is syncope without documented arrhythmias believed to be caused by a tachyarrhythmia based on clinical judgment. In other words, patients with typical vagal syncope will be counted as asymptomatic and will be accepted to the registry whereas patients with a clinical history suggesting syncope other than vagal syncope will not be accepted to this Registry. Genetic confirmation (identification of a disease-causing mutation) will not be required for establishing the diagnosis of Brugada syndrome but will be recorded when present. Patients with Questionable Brugada Syndrome who are asymptomatic. Patients with Questionable Brugada Syndrome are defined as patients with type II or III electrocardiogram who have an inconclusive result during a drug challenge with a sodium channel blocker. Asymptomatic is defined as above. Genetic testing will not be required. However, patients with Questionable Brugada based on electrocardiographic criteria will be defined as Patients with Brugada Syndrome if a disease-causing mutation is identified. Exclusion Criteria: A history of cardiac arrest, arrhythmic syncope or suspected arrhythmic syncope (as defined above). Evidence of organic heart disease. The evaluation considered mandatory for excluding heart disease will consist of electrocardiogram, echocardiogram and exercise stress testing. Additional tests will be performed only if clinically indicated. Evidence of non-cardiac disease likely to affect 5-year survival.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinidine<br>Patients with type I Brugada electrocardiogram (either spontaneous or following a drug challenge with sodium channel blocker) who never experienced arrhythmia-related symptoms. Patients will receive quinidine therapy at the discretion of the attending physician. | Drug: quinidine<br>* quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.<br>* Other names: Quiniduran;|
| Active Comparator: no therapy<br>Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician | Drug: quinidine<br>* quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.<br>* Other names: Quiniduran;Drug: no therapy<br>* No therapy; this is not a placebo-controlled trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias. |  | Long term (>5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brugada syndrome, quinidine, Asymptomatic Brugada Syndrome