EUCTR2009-014940-12-FR进行中（未招募）1 期
Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •- Male or female patients.
- •- Aged between 18 and 75 years (inclusive).
- •- ICD for primary or secondary prevention of ventricular arrhythmia for at least 3 months before selection.
- •- Symptomatic CHF for at least 6 months before selection.
- •- NYHA functional class II or III.
- •- Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF.
- •- Treatment with a beta-blocker for at least 3 months before selection.
- •- An average number of at least 100 premature ventricular complexes (PVCs) per hour on a 48-hour Holter ECG recording.
- •- LVEF = 40% at echocardiographic examination.
- •- Sinus rhythm.
- •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
- •- Unstable condition within 4 weeks before selection.
- •- Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation.
- •- History of stroke or cerebral transient ischemic attack within 3 months before selection.
- •- Severe primary aortic or mitral stenosis or regurgitation.
- •- Congenital heart disease.
- •- Hypertrophic obstructive cardiomyopathy.
- •- Cardiac resynchronisation therapy (CRT) started within 6 months before selection.
- •- Episode of reverted ventricular fibrillation or Torsade de Pointes within 4 weeks before selection.
- •- Atrio-ventricular block of second or third degree.
- •- Corrected QT interval duration (Bazett’s formula) > 480 ms.
研究者
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