Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

Brugada Syndrome Clinical Trial

— Quidam  

Official 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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00927732
• Other study ID #: 06/2-D
• Status: Terminated
• Phase: Phase 3
• First received: June 24, 2009
• Last updated: November 21, 2014
• Start date: February 2009
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

Drug:
• hydroquinidine
capsules of 300 mg LP, 1 or 2 or 3 times per day : frequency will be determined by tests after patient inclusion before her/his randomization
• placebo (sugar)
capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	CHU Grenoble	Grenoble
France	CHRU Lille	Lille
France	CHU Lyon	Lyon
France	AP-HM Marseille	Marseille
France	CHU Montpellier	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	AP-HP Paris Lariboisière	Paris
France	CHU Poitiers	Poitiers
France	CHU Rennes	Rennes
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)		3 years after patient randomization	No
Secondary	To evaluate number and frequency of inappropriate shock with and without hydroquinidine		3 years after patient randomization	No
Secondary	To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required any treatment		3 years after patient randomization	No
Secondary	To evaluate number of syncope reported by the patient but for which no ventricular arrhythmias has been detected by the defibrillator		3 years after patient randomization	No
Secondary	To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment		3 years after patient randomization	Yes
Secondary	To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine		3 years after patient randomization	No