EUCTR2009-011559-38-IT进行中（未招募）不适用
Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker. A 12-week, randomized, double-blind, parallel-group, placebo controlled, multicentre study. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
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 superior or equal to 18 years and less or equal to 75 years - Symptomatic chronic heart failure for at least 6 months before selection - NYHA functional class II or III - Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF - Left ventricular systolic dysfunction as evidence by a LVEF less or equal to 35% as measured within 6 months before selection - ACE inhibitor and/or ARB treatment for at least 3 months before selection - NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior to 100 pg/mL.
- •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
- •- Treatment with a beta-blocker within 2 months before selection. - Unstable condition within the previous 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 the previous 3 months before selection. - Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation. - Congenital heart disease. - Hypertrophic obstructive cardiomyopathy. - Pericardial disease. - Atrio-ventricular block of second or third degree. - Corrected QT interval duration (Bazett s formula) > 450 ms. - Family history of long QT syndrome or congenital long QT syndrome. - Serum creatinine > 200 micromoles/L (> 2.26 mg/dL). - ALAT or ASAT > 3 times the upper limit of normal values. - Serum total calcium < 2.1 mmol/L or > 2.6 mmol/L. - Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females)
研究者
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