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Sponsored by: |
International Registry of Asymptomatic Brugada Syndrome |
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Information provided by: | International Registry of Asymptomatic Brugada Syndrome |
ClinicalTrials.gov Identifier: | NCT00789165 |
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.
Condition | Intervention | Phase |
---|---|---|
Arrhythmia |
Drug: quinidine Drug: no therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome. |
Arms | Assigned Interventions |
---|---|
Quinidine: Experimental
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
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
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no therapy: Active Comparator
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
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Drug: no therapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with Asymptomatic Brugada syndrome.
Patients with Questionable Brugada Syndrome who are asymptomatic.
Exclusion Criteria:
Contact: Sami Viskin, M.D. | 97236973311 | saviskin@tasmc.health.gov.il |
United States, New York | |
Masonic Medical Research Laboratory | |
Utica, New York, United States, 13501-1787 | |
Israel | |
Tel Aviv Medical Center | |
Tel Aviv, Israel, 64239 | |
Japan | |
National Cardiovascular Center | |
Osaka, Japan | |
Netherlands | |
Arthur A. M. Wilde | |
Amsterdam, Netherlands |
Principal Investigator: | Sami Viskin, M.D. | Tel Aviv Medical Center |
Responsible Party: | Tel Aviv Medical Center ( Sami Viskin, M.D. ) |
Study ID Numbers: | 1297368, No grants at this point |
Study First Received: | November 8, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00789165 |
Health Authority: | Israel: Ministry of Health |
Brugada syndrome quinidine Asymptomatic Brugada Syndrome |
Heart Diseases Brugada syndrome Genetic Diseases, Inborn |
Quinidine Brugada Syndrome Arrhythmias, Cardiac |
Anti-Infective Agents Antiprotozoal Agents Neurotransmitter Agents Disease Cholinergic Antagonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Adrenergic alpha-Antagonists |
Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Antimalarials Antiparasitic Agents Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents |