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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00927732
Date of registration:	24/06/2009
Prospective Registration:	No
Primary sponsor:	Nantes University Hospital
Public title:	Hydroquinidine Versus Placebo in Patients With Brugada Syndrome Quidam
Scientific 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"
Date of first enrolment:	February 2009
Target sample size:	64
Recruitment status:	Terminated
URL:	http://clinicaltrials.gov/show/NCT00927732
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase:	Phase 3

Countries of recruitment
France

Contacts

Name:	A Amiel, Dr
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Affiliation:	CHU POITIERS

Name:	V Probst, Pr
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Affiliation:	CHU NANTES - Hôpital Laennec

Name:	JC Deharo, pr
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Affiliation:	CHU MARSEILLE

Name:	N Sadoul, Pr
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Affiliation:	CHU NANCY

Name:	M Haissaguerre, Pr
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Affiliation:	CHU BORDEAUX

Name:	A Leenhardt, Pr
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Affiliation:	CHU PARIS LARIBOISIERE

Name:	JM Dupuis, Dr
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Affiliation:	University Hospital, Angers

Name:	J Mansourati, Pr
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Affiliation:	CHU BREST

Name:	D Babuty, Pr
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Affiliation:	CHU TOURS

Name:	P Maury, Dr
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Affiliation:	CHU TOULOUSE

Name:	P Defaye, Dr
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Affiliation:	CHU GRENOBLE

Name:	M Chauvin, Pr
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Affiliation:	CHU STRASBOURG

Name:	S Kacet, Pr
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Affiliation:	CHRU Lille

Name:	JS Hermida, Pr
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Affiliation:	CHU AMIENS

Name:	P Chevallier, Pr
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Affiliation:	CHU Lyon

Name:	P Mabo, Pr
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Affiliation:	CHU RENNES

Name:	JM Davy, Pr
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Affiliation:	University Hospital, Montpellier

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Brugada Syndrome

Intervention(s)

Drug: hydroquinidine

Drug: placebo (sugar)

Primary Outcome(s)

To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia) [Time Frame: 3 years after patient randomization]

Secondary Outcome(s)

To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment [Time Frame: 3 years after patient randomization]

To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required any treatment [Time Frame: 3 years after patient randomization]

To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine [Time Frame: 3 years after patient randomization]

To evaluate number and frequency of inappropriate shock with and without hydroquinidine [Time Frame: 3 years after patient randomization]

To evaluate number of syncope reported by the patient but for which no ventricular arrhythmias has been detected by the defibrillator [Time Frame: 3 years after patient randomization]

Secondary ID(s)

06/2-D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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