EUCTR2012-001689-13-LV进行中（未招募）不适用
Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolicdysfunction. A 6 to 12-month randomised double blind parallel groups multicentre study.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •- Women or men;
- •- Age = 18 years;
- •- Symptomatic CHF, NYHA class II, III or IV for at least 6 weeks prior to selection;
- •- CHF from all aetiologies except from congenital heart disease or from severe aortic or mitral valva disease;
- •- Normal sinus rhythm;
- •- Resting heart rate =75bpm;
- •- Documented left ventricular systolic dysfunction.
- •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 434
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 266
排除标准
- •- Women who are pregnant, breast-feeding or women of childbearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estroprogestative or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study.
- •- Contra-indication to ivabradine, ivabradine not recommended or not effective, or requirement for a not recommended concomitant treatment (cf ivabradine SmPC);
- •- Previous cardiac transplantation or on list for cardiac transplantation;
- •- Patient treated with ivabradine in the month preceding the selection.
研究者
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