Hydroquinidine Versus Placebo in Patients With Brugada Syndrome (Quidam)
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| ClinicalTrials.gov Identifier: NCT00927732 |
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Recruitment Status :
Terminated
(insufficient recruitment, a lot of premature study discontinuations)
First Posted : June 25, 2009
Last Update Posted : November 24, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brugada Syndrome | Drug: hydroquinidine Drug: placebo (sugar) | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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" |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927732
Show 17 study locations
| 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 |
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00927732 |
| Other Study ID Numbers: |
06/2-D |
| First Posted: | June 25, 2009 Key Record Dates |
| Last Update Posted: | November 24, 2014 |
| Last Verified: | November 2014 |
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Brugada hydroquinidine ventricular arrhythmia patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator |
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Brugada Syndrome Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease Genetic Diseases, Inborn Quinidine Hydroquinidine Anti-Arrhythmia Agents 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 Cholinergic Agents Voltage-Gated Sodium Channel Blockers |