Empiric Quinidine for Asymptomatic Brugada Syndrome

NCT00789165 | Withdrawn Phase 2

• 2 other identifiers: 1297368No grants at this point
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 6

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

Keywords

Brugada syndrome; quinidine; Asymptomatic Brugada Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Long term (>5 years)

Study Arms (2)

Quinidine

EXPERIMENTAL

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

no therapy

ACTIVE COMPARATOR

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

Drug: quinidine; Drug: no therapy

Interventions

quinidine DRUG

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

Also known as: Serecor, Quiniduran

Quinidine; no therapy

no therapy DRUG

No therapy; this is not a placebo-controlled trial

no therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Registry of Asymptomatic Brugada Syndrome: lead

Study Sites (6)

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

University Medical Centre Mannheim

Mannheim, Germany

Location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

University of Pavia and IRCCS Fondazione Policlinico San Matteo

Pavia, Italy

Location

National Cardiovascular Center

Osaka, Japan

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Brugada Syndrome

Interventions

Quinidine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sami Viskin, M.D.

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: International RABS director

Study Record Dates

• First Submitted: November 8, 2008
• First Posted: November 11, 2008
• Study Start: December 1, 2009
• Primary Completion: February 1, 2020
• Study Completion: December 31, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

IT (1); DE (1); JP (1); NL (1); US (1); IL (1)