Status:
WITHDRAWN
Empiric Quinidine for Asymptomatic Brugada Syndrome
Lead Sponsor:
International Registry of Asymptomatic Brugada Syndrome
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 Syn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00789165
Start Date
December 1 2009
End Date
December 31 2020
Last Update
February 13 2020
Active Locations (6)
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1
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
2
University Medical Centre Mannheim
Mannheim, Germany
3
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
4
University of Pavia and IRCCS Fondazione Policlinico San Matteo
Pavia, Italy