Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Sanofi
• Treatments: Hydroquinidine; Quinidine

Criteria

Inclusion Criteria:

• Healthy adult (at least 18 years of age)

• Informed consent form signed

• Subject affiliated to French health insurance (Sécurité Sociale)

• Type 1 Brugada syndrome either symptomatic or asymptomatic

• Not pregnant, taking oral contraceptive measure if able to procreate

• If patient with asymptomatic type 1 Brugada, electrophysiological exploration must be positive at study inclusion

• No current intake of "betablocking" medicine used in cardiac insufficiency (bisoprolol, carvedilol, metoprolol)

• No current myasthenia

• No current treatment with halofantrine, pentamidine, moxifloxacin

• No current treatment with some neuroleptics

• Known hypersensitivity to hydroquinidine

• Intolerance to fructose, syndrome of glucose or galactose malabsorption, deficit in sucrase isomaltase- Cardiac insufficiency

• Histories of "torsades de pointe"

• Intake of medicine giving "torsades de pointe"

Exclusion Criteria:

• Subject not fulfilling inclusion criteria

• Subject being before study entry under hydroquinidine treatment but either at a dose > 3 capsules per day or at a dose of 1, 2 or 3 capsules per day but with a plasmatic hydroquinidine concentration >6µmol/L or <3 µmol/L