NL-OMON35783已完成2 期
Evaluation of the anti-arrhythmic effects of 3 oral dosages of S44121 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. - S44121 -006
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Selection criteria:
- •-Male or female, Aged ><=18 years and <<= 80 years
- •-Received an ICD for primary or secondary prevention of ventricular arrhythmia at least 3 months before selection,
- •-Symptomatic chronic heart failure for at least 6 months before selection,
- •-NYHA functional class I, II or III,
- •-Stable condition with regards to heart failure symptoms for at least 4 weeks before selection,
- •-Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF,
- •-Treated with optimal and unchanged CHF treatment and dosages for at least 4 weeks before selection,
- •-Treated with a maximal tolerated dosis beta-blocker for at least 3 months before selection (Patient can receive less than the daily target dose of the beta-blocker recommended in the ESC guidelines 2008)
- •- Regular sinusal or atrial rhythm, paced or spontaneous, and provided that atrial contraction preceeds ventricular contraction;
- •-Documentation of an average number of at least 100 PVCs per hour on a 48-hour Holter-based ECG recording (performed between the selection and the inclusion visit),
- •-Documentation of a LVEF<<= 40% during an echocardiographic examination performed between the selection and inclusion visit,
- •-Compliance to placebo (between 75% and 130% )
排除标准
- •Main non-selection criteria:
- •-Women who are pregnant,
- •-Women who are breast-feeding,
- •-Women of childbearing potential not using estro-progestative or progestative or intra-uterine contraception, or women using estro-progestative or progestative or intra-uterine contraception, but who consider stopping it during the planned duration of the study,
- •-Participation in another drug or device trial at the same time or during the 30 days prior to selection. Marketed drugs used for unapproved indications are considered to be investigational drugs,
- •-Unstable condition within the previous 4 weeks before selection (e.g. documented hospital admission due to worsening of chronic heart failure)
- •-Recent (less than 3 months before selection): myocardial infarction, unstable angina, coronary revascularisation,cerebral stroke or TIA
- •- Severe valvular disease, congenital heart disease or pericardial disease,
- •-Scheduled surgery for valvular heart disease, for revascularisation (PCI or CABG),
- •-Intracardiac thrombus,
- •-Active myocarditis,
- •-Previous cardiac transplantation or on list for cardiac transplantation,
- •-Cardiac resynchronisation therapy (CRT) started within the previous 3 months before selection,
- •-Change in the anti-arrhythmic treatment or dose within the previous 4 weeks before selection,
- •-Episode of reverted ventricular fibrillation or Torsade de Pointes in the last 4 weeks,
- •-History of cardioversion or ablation for to treat atrial fibrillation or ventricular tachycardia in the previous 3 months before selection,
- •-Atrio-ventricular block of second or third degree (documented on a resting ECG),
- •-Corrected QT interval duration (Bazett*s formula) > 480 ms,
- •-Family history of long QT syndrome or congenital long QT syndrome,
- •-INR < 1.4 or > 3.4 in patients taking anti-vitamin K oral anticoagulation,
- •-Severe or uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg),
- •-Systolic blood pressure < 90 mmHg,;Main non-inclusion criteria:
- •-Unstable clinical condition or change in the CHF or anti-arrhythmic treatment or dosage since the selection visit,
- •- Biological parameters: Sodium or Potassium out of range, creatinine > 200 *mol/L, ALAT and/or ASAT > x3 ULN
研究者
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