EUCTR2014-003641-95-ES进行中（未招募）不适用
Randomized clinical trial to study effective pharmacological cardioversion of paroxysmal atrial fibrillation by blocking ionic currents atrioselectivas by treatment with vernakalant vs Flecainide - SELECTI-CARFAP
icasio Pérez Castellano0 个研究点开始时间: 2014年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 Patients with paroxysmal atrial fibrillation with less of 48 hours of evolution.
- •2 Hemodynamically stable patients (systolic blood pressure> 100 mm Hg and <160 mm Hg. Diastolic blood pressure <95 mm Hg).
- •3 Weight from 45 to 136 kg.
- •4. Adequate anticoagulant therapy according to clinical practice guidelines of European Society of Cardiology in atrial fibrillation paroxysmal duration less of 48 hours.
- •5 Aging between 20 and 65 years old.
- •6 Patients must agree and be able to grant informed consent.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 QT interval> 440 milliseconds, long QT familiar syndrome or previous history of Torsades de Pointes syndrome.
- •2 Symptomatic bradycardia or ventricular rate <50 bpm without a pacemaker, or QRS interval> 140 milliseconds.
- •3 Patients with Class IV heart failure according to the New York Heart Association or congestive heart failure requiring intravenous inotropic therapy.
- •4. cardiogenic or septic shock, chronic myocardial infarction, acute coronary syndrome, or heart surgery in <30 days before recruitment.
- •5 valve stenosis, obstructive hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- •6. previous electrical cardioversion ineffective.
- •7 Having received an investigational drug within 60 days before inclusion or received vernakalant previously.
- •8 Secondary causes of atrial fibrillation, uncorrected electrolyte imbalance, or digoxin toxicity.
- •9 intravenous / oral treatment with class I or III antiarrhythmic drugs (except amiodarone) in the previous 48 hours.
- •10 intravenous / oral amiodarone within 3 months prior.
- •11 pregnant or nursing women.
- •12. intolerance or allergy to any of the two study drugs.
- •13 Patients who do not give their informed consent.
研究者
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