Trial record 2 of 8 for:    "Brugada syndrome"

Hydroquinidine Versus Placebo in Patients With Brugada Syndrome (Quidam)

This study has suspended participant recruitment.
(insufficient recruitment, a lot of premature study discontinuations)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00927732
First received: June 24, 2009
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Brugada Syndrome
Drug: hydroquinidine
Drug: placebo (sugar)
Phase 3

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
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"

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate number and frequency of inappropriate shock with and without hydroquinidine [ Time Frame: 3 years after patient randomization ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment [ Time Frame: 3 years after patient randomization ] [ Designated as safety issue: Yes ]
  • To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine [ Time Frame: 3 years after patient randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927732

Locations
France
CHU Amiens
Amiens, France, 80
CHU Angers
Angers, France, 49
CHU Bordeaux
Bordeaux, France, 33
CHU Brest
Brest, France, 29
CHU Grenoble
Grenoble, France, 38
CHRU Lille
Lille, France, 59
CHU Lyon
Lyon, France, 69
AP-HM Marseille
Marseille, France, 13
CHU Montpellier
Montpellier, France, 34
CHU Nancy
Nancy, France, 54
CHU Nantes
Nantes, France, 44093
AP-HP Paris Lariboisière
Paris, France, 75
CHU Poitiers
Poitiers, France, 86
CHU Rennes
Rennes, France, 35
CHU Strasbourg
Strasbourg, France, 67
CHU Toulouse
Toulouse, France, 31
CHU Tours
Tours, France, 37
Sponsors and Collaborators
Nantes University Hospital
Sanofi
Investigators
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 CHU 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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00927732     History of Changes
Other Study ID Numbers: 06/2-D
Study First Received: June 24, 2009
Last Updated: September 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Brugada
hydroquinidine
ventricular arrhythmia
patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator

Additional relevant MeSH terms:
Brugada Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Hydroquinidine
Quinidine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014