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Empiric Quinidine for Asymptomatic Brugada Syndrome
This study is not yet open for participant recruitment.
Verified by International Registry of Asymptomatic Brugada Syndrome, November 2008
Sponsored by: International Registry of Asymptomatic Brugada Syndrome
Information provided by: International Registry of Asymptomatic Brugada Syndrome
ClinicalTrials.gov Identifier: NCT00789165
  Purpose

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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia
Drug Information available for: Quinidine Quinidine polygalacturonate Quinidine sulfate
U.S. FDA Resources
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.

Further study details as provided by International Registry of Asymptomatic Brugada Syndrome:

Primary Outcome Measures:
  • Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias. [ Time Frame: Long term (>5 years) ] [ Designated as safety issue: Yes ]

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.
no therapy: Active Comparator
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
Drug: no therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789165

Contacts
Contact: Sami Viskin, M.D. 97236973311 saviskin@tasmc.health.gov.il

Locations
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
Sponsors and Collaborators
International Registry of Asymptomatic Brugada Syndrome
Investigators
Principal Investigator: Sami Viskin, M.D. Tel Aviv Medical Center
  More Information

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

Keywords provided by International Registry of Asymptomatic Brugada Syndrome:
Brugada syndrome
quinidine
Asymptomatic Brugada Syndrome

Study placed in the following topic categories:
Heart Diseases
Brugada syndrome
Genetic Diseases, Inborn
Quinidine
Brugada Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009