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Empiric Quinidine for Asymptomatic Brugada Syndrome

Primary Purpose

Arrhythmia

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
quinidine
no therapy
Sponsored by
International Registry of Asymptomatic Brugada Syndrome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia focused on measuring Brugada syndrome, quinidine, Asymptomatic Brugada Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lankenau Institute for Medical Research
  • University Medical Centre Mannheim
  • Tel Aviv Medical Center
  • University of Pavia and IRCCS Fondazione Policlinico San Matteo
  • National Cardiovascular Center
  • Academic Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quinidine

no therapy

Arm Description

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.

Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician

Outcomes

Primary Outcome Measures

Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2008
Last Updated
February 12, 2020
Sponsor
International Registry of Asymptomatic Brugada Syndrome
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1. Study Identification

Unique Protocol Identification Number
NCT00789165
Brief Title
Empiric Quinidine for Asymptomatic Brugada Syndrome
Official Title
A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Registry of Asymptomatic Brugada Syndrome

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Brugada syndrome, quinidine, Asymptomatic Brugada Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quinidine
Arm Type
Experimental
Arm Description
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.
Arm Title
no therapy
Arm Type
Active Comparator
Arm Description
Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
Intervention Type
Drug
Intervention Name(s)
quinidine
Other Intervention Name(s)
Serecor, Quiniduran
Intervention Description
quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Intervention Type
Drug
Intervention Name(s)
no therapy
Intervention Description
No therapy; this is not a placebo-controlled trial
Primary Outcome Measure Information:
Title
Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.
Time Frame
Long term (>5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: A history of cardiac arrest, "arrhythmic syncope" or "suspected arrhythmic syncope" (as defined above). 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. Evidence of non-cardiac disease likely to affect 5-year survival.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sami Viskin, M.D.
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
University Medical Centre Mannheim
City
Mannheim
Country
Germany
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
University of Pavia and IRCCS Fondazione Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
National Cardiovascular Center
City
Osaka
Country
Japan
Facility Name
Academic Medical Centre
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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Empiric Quinidine for Asymptomatic Brugada Syndrome

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