Hydroquinidine Versus Placebo in Patients With Brugada Syndrome (Quidam)

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 3

Conditions: Brugada Syndrome

Treatments: Drug: hydroquinidine; Drug: placebo (sugar)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00927732

06/2-D

Details and patient eligibility

About

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).

Full 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 (meaning for example hydroquinidine if treatment 1 was placebo). Time length before arisen of an appropriate shock registered on the defibrillator (meaning due to ventricular arrhythmia) will be assessed during treatment 1 period and treatment 2 period.We hypothesized that hydroquinidine administration will enhance time length before arisen of an appropriate shock and thus mean that hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia. Patient's defibrillator recordings will be analysed every 6 months plus when patient experiences an ICD shock. If the shock delivered by the ICD is appropriate and happens during treatment 1 period, patient will switch to treatment 2 period after 7 days of wash-out. If the shock delivered by the ICD is appropriate and happens during treatment 2 period, study will be finished for this patient.Before starting the study, each patient will test which dose of hydroquinidine she/he requires to have an hydroquinidine concentration in her/his blood included between 3 and 6 µmol/L.

Planned enrollment: 200 subjects (60 being symptomatic with histories of aborted sudden cardiac death or of ventricular fibrillation, 70 being symptomatic with histories of syncope considered as of arrhythmic origin, 70 being asymptomatic with a spontaneous type 1 ECG and a positive electrophysiological exploration)

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

hydroquinidine

Experimental group

Description:

As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.

Treatment:

Drug: hydroquinidine

capsules of sugar

Placebo Comparator group

Description:

As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.

Treatment:

Drug: placebo (sugar)