Status:
TERMINATED
Hydroquinidine Versus Placebo in Patients With Brugada Syndrome
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Brugada Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (IC...
Detailed Description
During this double-blind randomized cross-over study, patient will receive during 18 months treatment 1 (hydroquinidine or placebo) and, after 7 days of wash-out, patient will receive treatment 2 (mea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00927732
Start Date
February 1 2009
End Date
October 1 2014
Last Update
November 24 2014
Active Locations (17)
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1
CHU Amiens
Amiens, France, 80
2
CHU Angers
Angers, France, 49
3
CHU Bordeaux
Bordeaux, France, 33
4
CHU Brest
Brest, France, 29