Effects of ivabradine IV versus placebo on haemodynamic parameters in patients with a low cardiac output syndrome following planned coronary artery bypass surgery and requiring positive inotropic treatment. A phase II, single blind, exploratory, multicentre study.

Institut de Recherches Internationales Servier0 个研究点开始时间: 2010年2月2日最近更新: 2017年6月5日

适应症

试验速览

暂无简介。

•- Male or female of non childbearing potential,
•- Aged >= 18 years and < 75 years,
•- Patients presenting a LCOS following a planned CABG and requiring positive inotropic treatment with dobutamine as first line inotropic therapy,
•- normal sinus rhythm as documented by a resting standard 12-lead ECG,
•- coronary artery disease as documented by the coronary angiography,
•- left ventricular ejection fraction >= 20% >= 40%, documented by a trans-thoracic echocardiography within 1 month prior to the study enrolment,
•- HR >= 100 bpm after initiation of dobutamine infusion
•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

•- Patient with a clinically significant heart disease other than coronary heart disease
•- History of recurrent episodes of ventricular arrhythmia
•- History of permanent complete arrhythmia due to atrial fibrillation, flutter pacemaker or cardioverter-defibrillator implantation,
•- History of atrioventricular block of 2nd or 3rd degree,
•- Trifascicular block and PR > 240 msec,
•- Symptomatic hypotension or hypotension with SBP < 85 mmHg,
•- Severe or uncontrolled hypertension
•- LCOS occuring after a septic shock

发起方