Evaluation of the effects of 3 successive oral dosages (2.5; 5; 7.5 mg b.i.d.) of ivabradine in patients with stable moderate to severe systolic chronic heart failure treated with beta-blockers. A 9 week pilot, open labelled, international multicenter study

Institut de Recherches Internationales Servier0 个研究点目标入组 80 人开始时间: 2005年6月14日最近更新: 2012年3月19日

适应症

试验速览

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•Selection criteria: Male or female patients over 18 years; syptomatic chronic heart failure class III or IV NYHA since at least 3 months; in stable condition since at least 4 weeks; patients with optimal and stable heart failure treatment for at least 4 weeks including beta-blockers and ACE inhibitors (unless contra-indicated); documented hospital admission within the previous 12 months with discharge diagnosis of chronic heart failure; ischaemic or non ischaemic heart disease; sinus rhythm and heart rate >= 60 bpm; informed consent. Sinus rhythm, heart rate > 60 bpm on resting ECG, left ventricular ejection fraction < 35% from the two-dimensioned echocardiography.
•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

•Non-selection criteria: Women of childbearing potential not using adequate contraception, unstable cardiovascular condition, significant valvulopathy, active myocarditis, transplanted heart, known severe liver or renal disease, cardiac surgery scheduled within the next 9 weeks, contraindications to the administration of ivabradine, treatment with drug unauthorised during the study.

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