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

Status: Terminated
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
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• 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

Locations
Other Locations
France
CHU Amiens
Amiens
CHU Angers
Angers
CHU Bordeaux
Bordeaux
CHU Brest
Brest
CHU Grenoble
Grenoble
CHRU Lille
Lille
CHU Lyon
Lyon
AP-HM Marseille
Marseille
CHU Montpellier
Montpellier
CHU Nancy
Nancy
CHU Nantes
Nantes
AP-HP Paris Lariboisière
Paris
CHU Poitiers
Poitiers
CHU Rennes
Rennes
CHU Strasbourg
Strasbourg
CHU Toulouse
Toulouse
CHU Tours
Tours
Time Frame
Start Date: February 2009
Completion Date: October 2014
Participants
Target number of participants: 64
Treatments
Experimental: hydroquinidine
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.
Placebo Comparator: capsules of sugar
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.
Authors
Sponsors
Leads: Nantes University Hospital
Collaborators: Sanofi

This content was sourced from clinicaltrials.gov

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