Expired Study
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Wynnewood, Pennsylvania 19096


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.


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.


Study is Available At:


Original ID:

1297368


NCT ID:

NCT00789165


Secondary ID:

No grants at this point


Study Acronym:


Brief Title:

Empiric Quinidine for Asymptomatic Brugada Syndrome


Official Title:

A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.


Overall Status:

Active, not recruiting


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

International Registry of Asymptomatic Brugada Syndrome


Oversight Authority:

Israel: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sami Viskin, M.D.
Principal Investigator
Tel Aviv Medical Center

Study Dates

Start Date:December 2009
Completion Date:December 31, 2020
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 7, 2019
First Received Date:November 8, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.
Time Frame:Long term (>5 years)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:quinidine
Description:quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.
Arm Name:Quinidine
Other Name:Serecor
Intervention Type:Drug
Name:no therapy
Description:No therapy; this is not a placebo-controlled trial
Arm Name:no therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Quinidine
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.
Study Arm Type:Active Comparator
Arm Name:no therapy
Description:Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:International Registry of Asymptomatic Brugada Syndrome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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