Patients with syndroma of Brugada who have an automatic implantable cardiac defibrillator MedDRA version: 9.1 Level: LLT Classification code 10059027 Term: Brugada syndrome
Conditions
Interventions
Trade Name: SERECOR
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Centre Hospitalier Universitaire de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria for inclusion: Patients aged 18 or > 18, presenting a type I Brugada syndrome, having an Implantable Automatic Defibrillator (IAD) and being either symptomatic [ previous occurrence of cardiac arrest or ventricular fibrillation reduced by the IAD, OR previous occurrence of syncope suggesting cardiac rhythm trouble] or either asymptomatic, all patients being affiliated to social security, having given their written informed consent, having no known allergy to hydroquinidine. Criteria for randomization : - Those above listed - For patients with asymptomatic Brugada syndrome: positive electrophysiological exploration at the visit of inclusion - Absence of hypersensitivity reaction after intake of one capsule of hydroquinidine - No relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment - No relevant abnormality in blood formula The study will allow the randomization of: - 60 patients with symptomatic type I Brugada syndrome having presented a cardiac arrest or a ventricular fibrillation reduced by the IAD - 70 patients symptomatic type I Brugada syndrome who have presented a syncope suggesting cardiac rhythm trouble - 70 patients asymptomatic but with spontaneous type I electrocardiogram and for which the electrophysiological exploration induced a severe rhythm trouble Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Criteria of non inclusion : - Patients not presenting the inclusion criteria - Pregnancy or lactation - Female of procreating age without contraceptive methods - contra-indications to the use of hydroquinidine (ex: intolerance to fructose, myasthenia,…) Criteria for non randomization : - Those above listed - Patient with asymptomatic Brugada syndrome presenting a negative electrophysiological exploration at the visit of inclusion - Hypersensitivity reaction after intake of one capsule of hydroquinidine - Relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment - Relevant abnormality in blood formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare for patients with Brugada syndrome having an Implantable Automatic Defibrillator (IAD) the time length before the happening of an appropriate electric shock registered on the IAD when they are under hydroquinidine treatment or when they are under placebo (double-blinded cross-over study design);Secondary Objective: Secondary objectives: - To evaluate the number and frequency of inappropriate shocks with or without hydroquinidine treatment - - To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required a treatment - To evaluate the number of syncopes encountered by the patient for which no rhythm trouble was recorded on the defibrillator - To evaluate the number and frequency of indesirable adverse events occurring during treatment with hydroquinidine - To evaluate the interest of the electrophysiological exploration to determine the chances of success of a treatment with hydroquinidine - To analyse the delay of occurrence of a rhythm trouble with or without hydroquinidine treatment in relation to the patient genetic status (mutation or not on the SCN5A gene) ;Primary end point(s): Occurrence of an appropriate electric shock registered on the implantable automatic defibrillator will led to: - to change of treatment arm if the patient was in the first phase of treatment - - study drop out if the patient was in the second phase of treatment | — |
Countries
France
Outcome results
None listed