EUCTR2005-002809-23-ES进行中（未招募）1 期
Electrophysiological effects of Irbesartan in patients with paroxysmal AFEfectos electrofisiológicos del Irbesartán en sujetos con FA paroxística
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Subjects whose signed written informed consent has been obtained
- •2) Subjects with documented (on at least one ECG at any moment) recurrent paroxysmal atrial fibrillation who have an indication (and are going to be admitted) for catheter ablation techniques for atrial fibrillation.
- •3) Men and women, ages 18 to 70 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Structural cardiopathy like hypertensive cardiopathy, familiar cardiomyopathy, LVH, valvular disease, CAD, amyloidosis.
- •2) AF due to a reversible cause
- •3) History of thromboembolism during the previous year,
- •4) Previously documented and /or at visit 1 long QTc > 450 msec
- •5) Recent MI (less than 6 months), recent stroke (less than 6 months), severe HTN , subjects who require ACEi/ARBs .
- •6) Subjects with significant liver disease and coagulation problems
- •7) Subjects with inability to follow protocol procedures according to the investigation
- •8) Subjects with dementia
- •9) Subjects unable to come back at all follow up visits
- •10) Subjects with known intolerance to ARBs
- •11) Subjects treated with ACEI or ARB during the previous 4 weeks are excluded. A two-week wash out period is permitted.
- •12) Subjects treated with amiodarone during the previous six months will be excluded.
- •13) Any drug that could modify electrophysiological parameters: Antiarrythmic drugs including digoxine
- •14) Drugs with effect on QT intervals like:
- •a) Disopyramide, Dofetilide, Ibutilide, Procainamide, Quinidine, Sotalol, Bepridil. Probucol.
- •b) Other drugs: Amiodarone, Arsenic trioxide, Cisapride, Calcium-channel blockers: lidoflazine
- •c) Antiinfective agents: clarithromycin, erythromycin, halofantrine, pentamidine, sparfloxacin
- •d) Antiemetic agents: domperidone, droperidol
- •e) Antipsychotic agents: chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, Methadone
- •15) Prisoners or subjects who are compulsorily detained
- •16) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
研究者
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