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

Status: Withdrawn
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 Syndrome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Pennsylvania
Lankenau Institute for Medical Research
Wynnewood
Other Locations
Germany
University Medical Centre Mannheim
Mannheim
Israel
Tel Aviv Medical Center
Tel Aviv
Italy
University of Pavia and IRCCS Fondazione Policlinico San Matteo
Pavia
Japan
National Cardiovascular Center
Osaka
Netherlands
Academic Medical Centre
Amsterdam
Time Frame
Start Date: December 2009
Completion Date: December 31, 2020
Treatments
Experimental: Quinidine
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.
Active Comparator: no therapy
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
Authors
Peter J Schwartz, Boris Rudic, Hanno L. Tan, Charles Antzelevitch, Bernard Belhassen, Wataru Shimizu, Lia Crotti, Sami Viskin, Arthur AM Wilde
Sponsors
Leads: International Registry of Asymptomatic Brugada Syndrome

This content was sourced from clinicaltrials.gov

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