Empiric Quinidine for Asymptomatic Brugada Syndrome

NCT ID: NCT00789165

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Arrhythmia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

quinidine

Intervention Type: DRUG

quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.

no therapy

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

Group Type: ACTIVE_COMPARATOR

quinidine

Intervention Type: DRUG

quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.

no therapy

Intervention Type: DRUG

No therapy; this is not a placebo-controlled trial

Interventions

quinidine

quinidine at highest tolerated dose. Expected doses are hydroquinidine 600 - 900 mg daily.

Intervention Type: DRUG

no therapy

No therapy; this is not a placebo-controlled trial

Intervention Type: DRUG

Other Intervention Names

Serecor; Quiniduran

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Registry of Asymptomatic Brugada Syndrome

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sami Viskin

International RABS director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sami Viskin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

University Medical Centre Mannheim

Mannheim, , Germany

Tel Aviv Medical Center

Tel Aviv, , Israel

University of Pavia and IRCCS Fondazione Policlinico San Matteo

Pavia, , Italy

National Cardiovascular Center

Osaka, , Japan

Academic Medical Centre

Amsterdam, , Netherlands

Countries

United States; Germany; Israel; Italy; Japan; Netherlands

Other Identifiers

No grants at this point

Identifier Type: -

Identifier Source: secondary_id

1297368

Identifier Type: -

Identifier Source: org_study_id