Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

Summary

The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).

Conditions

• Brugada Syndrome

Interventions

DRUG

hydroquinidine

capsules of 300 mg LP, 1 or 2 or 3 times per day : frequency will be determined by tests after patient inclusion before her/his randomization

DRUG

placebo (sugar)

capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• Nantes University Hospital

  lead OTHER

Principal Investigators

• V Probst, Pr · CHU NANTES - Hôpital Laennec

• JM Dupuis, Dr · University Hospital, Angers

• JS Hermida, Pr · CHU AMIENS

• M Haissaguerre, Pr · University Hospital, Bordeaux

• J Mansourati, Pr · CHU BREST

• P Defaye, Dr · University Hospital, Grenoble

• S Kacet, Pr · CHRU LILLE

• P Chevallier, Pr · Hospices Civils de Lyon

• JC Deharo, pr · CHU MARSEILLE

• JM Davy, Pr · University Hospital, Montpellier

• N Sadoul, Pr · CHU NANCY

• A Leenhardt, Pr · CHU PARIS LARIBOISIERE

• A Amiel, Dr · CHU Poitiers

• P Mabo, Pr · CHU Rennes

• M Chauvin, Pr · CHU STRASBOURG

• D Babuty, Pr · CHU Tours

• P Maury, Dr · University Hospital, Toulouse

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• France

Study Locations