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Empiric Quinidine for Asymptomatic Brugada Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00789165
Recruitment Status : Withdrawn
First Posted : November 11, 2008
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Sami Viskin, International Registry of Asymptomatic Brugada Syndrome

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 Syndrome.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: quinidine Drug: no therapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.
Study Start Date : December 2009
Actual Primary Completion Date : February 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
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.
Drug: quinidine
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Other Names:
  • Serecor
  • Quiniduran

Active Comparator: no therapy
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
Drug: quinidine
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Other Names:
  • Serecor
  • Quiniduran

Drug: no therapy
No therapy; this is not a placebo-controlled trial




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789165


Locations
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United States, Pennsylvania
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Germany
University Medical Centre Mannheim
Mannheim, Germany
Israel
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Italy
University of Pavia and IRCCS Fondazione Policlinico San Matteo
Pavia, Italy
Japan
National Cardiovascular Center
Osaka, Japan
Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
International Registry of Asymptomatic Brugada Syndrome
Investigators
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Principal Investigator: Sami Viskin, M.D. Tel Aviv Medical Center

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Responsible Party: Dr. Sami Viskin, International RABS director, International Registry of Asymptomatic Brugada Syndrome
ClinicalTrials.gov Identifier: NCT00789165    
Other Study ID Numbers: 1297368
No grants at this point
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Keywords provided by Dr. Sami Viskin, International Registry of Asymptomatic Brugada Syndrome:
Brugada syndrome
quinidine
Asymptomatic Brugada Syndrome
Additional relevant MeSH terms:
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Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn
Quinidine
Quinidine gluconate
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP2D6 Inhibitors