Empiric Quinidine for Asymptomatic Brugada Syndrome



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:December 2009
End Date:December 31, 2020

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

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.


Inclusion Criteria:

1. 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.

2. 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:

1. A history of cardiac arrest, "arrhythmic syncope" or "suspected arrhythmic syncope"
(as defined above).

2. 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.

3. Evidence of non-cardiac disease likely to affect 5-year survival.
We found this trial at
2
sites
Wynnewood, Pennsylvania 19096
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from
Wynnewood, PA
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Mannheim,
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