Empiric Quinidine for Asymptomatic Brugada Syndrome

Phase 2

Withdrawn

• Conditions: Arrhythmia
• Interventions: Drug: quinidine; Drug: no therapy

• Registration Number: NCT00789165
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-08
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Study Start: 2009-12
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no therapy	no therapy	Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician
Quinidine	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.
no therapy	quinidine	Patients with asymptomatic Brugada syndrome who opted to receive no therapy following the recommendation of their attending physician

Primary Outcome Measures

Name	Time	Method
Combined endpoint of all cause mortality and spontaneous life-threatening arrhythmias.	Long term (>5 years)

Trial Locations

Locations (6)

Academic Medical Centre; 🇳🇱 Amsterdam, Netherlands

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel

National Cardiovascular Center; 🇯🇵 Osaka, Japan

Lankenau Institute for Medical Research; 🇺🇸 Wynnewood, Pennsylvania, United States

University of Pavia and IRCCS Fondazione Policlinico San Matteo; 🇮🇹 Pavia, Italy

University Medical Centre Mannheim; 🇩🇪 Mannheim, Germany