Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-29 @ 10:08 PM
Study NCT ID:
NCT00927732
Status:
TERMINATED
Last Update Posted:
2014-11-24
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroquinidine Versus Placebo in Patients With Brugada Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014486', 'term': 'hydroquinidine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'insufficient recruitment, a lot of premature study discontinuations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2009-06-24', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)', 'timeFrame': '3 years after patient randomization'}], 'secondaryOutcomes': [{'measure': 'To evaluate number and frequency of inappropriate shock with and without hydroquinidine', 'timeFrame': '3 years after patient randomization'}, {'measure': 'To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required any treatment', 'timeFrame': '3 years after patient randomization'}, {'measure': 'To evaluate number of syncope reported by the patient but for which no ventricular arrhythmias has been detected by the defibrillator', 'timeFrame': '3 years after patient randomization'}, {'measure': 'To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment', 'timeFrame': '3 years after patient randomization'}, {'measure': 'To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine', 'timeFrame': '3 years after patient randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brugada', 'hydroquinidine', 'ventricular arrhythmia', 'patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator'], 'conditions': ['Brugada Syndrome']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nPlanned 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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult (at least 18 years of age)\n* Informed consent form signed\n* Subject affiliated to French health insurance (Sécurité Sociale)\n* Type 1 Brugada syndrome either symptomatic or asymptomatic\n* Not pregnant, taking oral contraceptive measure if able to procreate\n* If patient with asymptomatic type 1 Brugada, electrophysiological exploration must be positive at study inclusion\n* No current intake of "betablocking" medicine used in cardiac insufficiency (bisoprolol, carvedilol, metoprolol)\n* No current myasthenia\n* No current treatment with halofantrine, pentamidine, moxifloxacin\n* No current treatment with some neuroleptics\n* Known hypersensitivity to hydroquinidine\n* Intolerance to fructose, syndrome of glucose or galactose malabsorption, deficit in sucrase isomaltase- Cardiac insufficiency\n* Histories of "torsades de pointe"\n* Intake of medicine giving "torsades de pointe"\n\nExclusion Criteria:\n\n* Subject not fulfilling inclusion criteria\n* 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'}, 'identificationModule': {'nctId': 'NCT00927732', 'acronym': 'Quidam', 'briefTitle': 'Hydroquinidine Versus Placebo in Patients With Brugada Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': '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"', 'orgStudyIdInfo': {'id': '06/2-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hydroquinidine', 'description': '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.', 'interventionNames': ['Drug: hydroquinidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'capsules of sugar', 'description': '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.', 'interventionNames': ['Drug: placebo (sugar)']}], 'interventions': [{'name': 'hydroquinidine', 'type': 'DRUG', 'otherNames': ['Hydroquinidine is commercialized as Serecor'], 'description': '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', 'armGroupLabels': ['hydroquinidine']}, {'name': 'placebo (sugar)', 'type': 'DRUG', 'description': 'capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine', 'armGroupLabels': ['capsules of sugar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29', 'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '38', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69', 'city': 'Lyon', 'country': 'France', 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13', 'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Paris Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'V Probst, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANTES - Hôpital Laennec'}, {'name': 'JM Dupuis, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Angers'}, {'name': 'JS Hermida, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU AMIENS'}, {'name': 'M Haissaguerre, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'J Mansourati, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU BREST'}, {'name': 'P Defaye, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Grenoble'}, {'name': 'S Kacet, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU LILLE'}, {'name': 'P Chevallier, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'JC Deharo, pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU MARSEILLE'}, {'name': 'JM Davy, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'N Sadoul, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU NANCY'}, {'name': 'A Leenhardt, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU PARIS LARIBOISIERE'}, {'name': 'A Amiel, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Poitiers'}, {'name': 'P Mabo, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Rennes'}, {'name': 'M Chauvin, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU STRASBOURG'}, {'name': 'D Babuty, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Tours'}, {'name': 'P Maury, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}