Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00927732
Previous Study | Return to List | Next Study

Hydroquinidine Versus Placebo in Patients With Brugada Syndrome (Quidam)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927732
Recruitment Status : Terminated (insufficient recruitment, a lot of premature study discontinuations)
First Posted : June 25, 2009
Last Update Posted : November 24, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date November 24, 2014
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • To evaluate number and frequency of inappropriate shock with and without hydroquinidine [ 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 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 ]
  • To evaluate the number and frequency of adverse events appeared under hydroquinidine 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroquinidine Versus Placebo in Patients With Brugada Syndrome
Official Title  ICMJE 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"
Brief 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).
Detailed 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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brugada Syndrome
Intervention  ICMJE
  • 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
    Other Name: Hydroquinidine is commercialized as Serecor
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: hydroquinidine
  • 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.
    Intervention: Drug: placebo (sugar)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 21, 2014)
64
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
200
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00927732
Other Study ID Numbers  ICMJE 06/2-D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: V Probst, Pr CHU NANTES - Hôpital Laennec
Study Chair: JM Dupuis, Dr University Hospital, Angers
Study Chair: JS Hermida, Pr CHU AMIENS
Study Chair: M Haissaguerre, Pr CHU Bordeaux
Study Chair: J Mansourati, Pr CHU BREST
Study Chair: P Defaye, Dr University Hospital, Grenoble
Study Chair: S Kacet, Pr CHRU Lille
Study Chair: P Chevallier, Pr CHU LYON
Study Chair: JC Deharo, pr CHU MARSEILLE
Study Chair: JM Davy, Pr University Hospital, Montpellier
Study Chair: N Sadoul, Pr CHU NANCY
Study Chair: A Leenhardt, Pr CHU PARIS LARIBOISIERE
Study Chair: A Amiel, Dr CHU Poitiers
Study Chair: P Mabo, Pr CHU Rennes
Study Chair: M Chauvin, Pr CHU STRASBOURG
Study Chair: D Babuty, Pr CHU Tours
Study Chair: P Maury, Dr CHU Toulouse
PRS Account Nantes University Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP