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Hydroquinidine Versus Placebo in Patients With Brugada Syndrome

NCT ID: NCT00927732

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-10-31

Brief Summary

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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).

Detailed Description

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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)

Conditions

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Brugada Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

hydroquinidine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

placebo (sugar)

Intervention Type DRUG

capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Hydroquinidine is commercialized as Serecor

Eligibility Criteria

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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"

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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V Probst, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU NANTES - Hôpital Laennec

JM Dupuis, Dr

Role: STUDY_CHAIR

University Hospital, Angers

JS Hermida, Pr

Role: STUDY_CHAIR

CHU AMIENS

M Haissaguerre, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux

J Mansourati, Pr

Role: STUDY_CHAIR

CHU BREST

P Defaye, Dr

Role: STUDY_CHAIR

University Hospital, Grenoble

S Kacet, Pr

Role: STUDY_CHAIR

CHRU LILLE

P Chevallier, Pr

Role: STUDY_CHAIR

Hospices Civils de Lyon

JC Deharo, pr

Role: STUDY_CHAIR

CHU MARSEILLE

JM Davy, Pr

Role: STUDY_CHAIR

University Hospital, Montpellier

N Sadoul, Pr

Role: STUDY_CHAIR

CHU NANCY

A Leenhardt, Pr

Role: STUDY_CHAIR

CHU PARIS LARIBOISIERE

A Amiel, Dr

Role: STUDY_CHAIR

CHU Poitiers

P Mabo, Pr

Role: STUDY_CHAIR

CHU Rennes

M Chauvin, Pr

Role: STUDY_CHAIR

CHU STRASBOURG

D Babuty, Pr

Role: STUDY_CHAIR

CHU Tours

P Maury, Dr

Role: STUDY_CHAIR

University Hospital, Toulouse

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CHU Brest

Brest, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CHRU Lille

Lille, , France

Site Status

CHU Lyon

Lyon, , France

Site Status

AP-HM Marseille

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU Nancy

Nancy, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

AP-HP Paris Lariboisière

Paris, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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06/2-D

Identifier Type: -

Identifier Source: org_study_id