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
Drug: placebo (sugar)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00927732
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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"
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
All locations for NCT00927732
Amiens, France, 80
Angers, France, 49
Bordeaux, France, 33
Brest, France, 29
Grenoble, France, 38
Lille, France, 59
Lyon, France, 69
Marseille, France, 13
Montpellier, France, 34
Nancy, France, 54
Nantes, France, 44093
AP-HP Paris Lariboisière
Paris, France, 75
Poitiers, France, 86
Rennes, France, 35
Strasbourg, France, 67
Toulouse, France, 31
Tours, France, 37
View full eligibility
Tris trial is registered with FDA with number: NCT00927732. The sponsor of the trial is Nantes University Hospital and it is looking for 64 volunteers for the current phase.
Official trial title: BRD 06/2-D (Quidam) "Evaluation of the Interest of Oral Hydroquinidine Administration to Treat Patients With Brugada Syndrome, High Cardiac Arrhythmic Risk and Implanted With an Implantable Cardioverter Defibrillator"
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