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.

Institut de Recherches Internationales Servier0 个研究点目标入组 160 人开始时间: 2011年4月21日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- Male or female patients.
•- Aged between 18 and 80 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 I, 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 or atrial rhythm (paced or spontaneous).
•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 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•- 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 3 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.

发起方