Empiric Quinidine for Asymptomatic Brugada Syndrome

This study is currently recruiting participants.
Verified September 2012 by International Registry of Asymptomatic Brugada Syndrome
Sponsor:
Information provided by (Responsible Party):
Dr. Sami Viskin, International Registry of Asymptomatic Brugada Syndrome
ClinicalTrials.gov Identifier:
NCT00789165
First received: November 8, 2008
Last updated: September 28, 2012
Last verified: September 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.

Resource links provided by NLM:


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 ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Quinidine
  • 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
  • Quinidine
  • Quiniduran
Drug: no therapy
No therapy; this is not a placebo-controlled trial

  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 Not yet recruiting
Utica, New York, United States, 13501-1787
Contact: Charles Antzelevitch, PhD, FACC, FAHA, FHRS    (315) 735-2217 ext 117    ca@mmrl.edu   
Principal Investigator: Charles Antzelevitch, PhD, FACC, FAHA, FHRS         
Germany
University Medical Centre Mannheim Recruiting
Mannheim, Germany
Contact: Boris Rudic, MD       boris.rudic@umm.de   
Principal Investigator: Boris Rudic, MD         
Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Sami Viskin, M.D.    972524266859    saviskin@tasmc.health.gov.il   
Sub-Investigator: Bernard Belhassen, M.D.         
Italy
University of Pavia and IRCCS Fondazione Policlinico San Matteo Recruiting
Pavia, Italy
Contact: Lia Crotti, MD PhD       l.crotti@smatteo.pv.it   
Sub-Investigator: Lia Crotti, MD PhD         
Principal Investigator: Peter J Schwartz, MD         
Japan
National Cardiovascular Center Recruiting
Osaka, Japan
Contact: Wataru Shimizu, M.D.       :wshimizu@hsp.ncvc.go.jp   
Principal Investigator: Wataru Shimizu, M.D.         
Netherlands
Academic Medical Centre Recruiting
Amsterdam, Netherlands
Contact: Arthur AM Wilde, M.D.       a.a.wilde@amc.uva.nl   
Sub-Investigator: Hanno L. Tan, M.D. PhD         
Principal Investigator: Arthur AM Wilde, MD PhD         
Sponsors and Collaborators
International Registry of Asymptomatic Brugada Syndrome
Investigators
Principal Investigator: Sami Viskin, M.D. Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: Dr. Sami Viskin, International RABS director, International Registry of Asymptomatic Brugada Syndrome
ClinicalTrials.gov Identifier: NCT00789165     History of Changes
Other Study ID Numbers: 1297368, No grants at this point
Study First Received: November 8, 2008
Last Updated: September 28, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Brugada Syndrome
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Genetic Diseases, Inborn
Quinidine
Quinidine gluconate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014