A Phase 3 interventional study of hydroquinidine and placebo (sugar) in Brugada Syndrome, sponsored by Nantes University Hospital. Terminated at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-24.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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).
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)
52 studies on the registry are indexed under Brugada Syndrome; 18 are open to participants now.
This study's enrollment of 64 is below the median of 123 across 19 interventional studies indexed under Brugada Syndrome.
Browse Brugada Syndrome studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
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
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 300 mg LP, 1 or 2 or 3 times per day : frequency will be determined by tests after patient inclusion before her/his randomization
Also known as: Hydroquinidine is commercialized as Serecor
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
This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital