Brugada SyndromePhase 3QuidamNCT00927732
Hydroquinidine Versus Placebo in Patients With Brugada Syndrome
A Phase 3 study testing hydroquinidine in people with Brugada Syndrome, run by Nantes University Hospital at 17 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- hydroquinidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 17 sitesFrance
- Study dates
- Feb 2009to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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"
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Amiens
Amiens, 80
CHU Angers
Angers, 49
CHU Bordeaux
Bordeaux, 33
CHU Brest
Brest, 29
CHU Grenoble
Grenoble, 38
CHRU Lille
Lille, 59
CHU Lyon
Lyon, 69
AP-HM Marseille
Marseille, 13
CHU Montpellier
Montpellier, 34
CHU Nancy
Nancy, 54
CHU Nantes
Nantes, 44093
AP-HP Paris Lariboisière
Paris, 75
CHU Poitiers
Poitiers, 86
CHU Rennes
Rennes, 35
CHU Strasbourg
Strasbourg, 67
CHU Toulouse
Toulouse, 31
CHU Tours
Tours, 37
About this study
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"
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).
Read the 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)
- Conditions
- Brugada Syndrome
- Being tested
- hydroquinidine, placebo (sugar)
- Keywords
- Brugada, hydroquinidine, ventricular arrhythmia, patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroquinidineDrug
Also called Hydroquinidine is commercialized as Serecor
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
placebo (sugar)Drug
capsules of placebo have same design and color than capsules of hydroquinidine except for their content as they contain sugar and not hydroquinidine
| Study group | Role | What they receive |
|---|---|---|
| hydroquinidine | Experimental | 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. Receives: Drug: hydroquinidine |
| capsules of sugar | Placebo comparator | 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. Receives: Drug: placebo (sugar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)
Measured: 3 years after patient randomization
Secondary outcomes (5)
To evaluate number and frequency of inappropriate shock with and without hydroquinidine
Measured: 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
Measured: 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
Measured: 3 years after patient randomization
To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment
Measured: 3 years after patient randomization
To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine
Measured: 3 years after patient randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: insufficient recruitment, a lot of premature study discontinuations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- V Probst, Pr, Principal investigator, CHU NANTES - Hôpital LaennecJM Dupuis, Dr, Study chair, University Hospital, AngersJS Hermida, Pr, Study chair, CHU AMIENSM Haissaguerre, Pr, Study chair, University Hospital, BordeauxJ Mansourati, Pr, Study chair, CHU BRESTP Defaye, Dr, Study chair, University Hospital, GrenobleS Kacet, Pr, Study chair, CHRU LILLEP Chevallier, Pr, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927732
- Sponsor's protocol ID
- 06/2-D
- Acronym
- Quidam
- Status last verified
- Nov 2014
- First submitted
- 24 Jun 2009
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT00927732
- Acronym / sponsor ID
- Quidam / 06/2-D
- Conditions
- Brugada Syndrome
- Keywords
- Brugada, hydroquinidine, ventricular arrhythmia, patients with Brugada syndrome, high cardiac arrhythmic risk and implanted with an implantable cardioverter defibrillator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment, a lot of premature study discontinuations
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroquinidine | Experimental | Drug: hydroquinidineAs 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. |
| capsules of sugar | Placebo comparator | Drug: placebo (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroquinidineAlso: Hydroquinidine is commercialized as Serecorcapsules 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 | Drug | hydroquinidine |
| 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 | Drug | capsules of sugar |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: insufficient recruitment, a lot of premature study discontinuations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
V Probst, Pr principal investigator
CHU NANTES - Hôpital Laennec
JM Dupuis, Dr study chair
University Hospital, Angers
JS Hermida, Pr study chair
CHU AMIENS
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydroquinidine in people with Brugada Syndrome, run by Nantes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment, a lot of premature study discontinuations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 3 years after patient randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.