NL-OMON35472撤回不适用
The evaluation of the effect of S 44121 (ryanodine channel complex stabilizer) on MTWA in patients with chronic heart failure (CHF). - Calcium cycling dynamics and MTWA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Male or female, Aged >=18 years and<= 85 years
- •-Received an lCD 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 Ill,
- •-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
- •-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 bela-blocker recommended in the ESC
- •guidelines 2008)
- •- Regular sinusal or atrial rhythm, paced or spontaneous, and provided that atrial contraction
- •preceeds ventricular contraction
排除标准
- •-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
- •-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 pericardia! disease,
- •-Scheduled surgery for valvular heart disease, for revascularisation (PC I or CABG),
- •-Jntracardiac thrombus,
- •-Active myocarditis,
- •-Previous cardiac transplantation or on Jist 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),
- •-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 ~molll, ALA T and/or
- •ASAT > x3 ULN
- •-Systolic blood pressure < 90 mmHg
研究者
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