EUCTR2016-004193-18-HU进行中（未招募）1 期
Effect of repetitive levosimendan treatment on clinical outcomes of chronic heart failure patients: focus on optimal patient selection based on novel cardiac biomarkers.
Semmelweis University, Heart and Vascular Center0 个研究点开始时间: 2016年10月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Symptomatic heart failure at enrollment – NYHA III-IV treated with augmented / iv. diuretics with optimal heart failure medical treatment
- •2. Ischaemic patients (no STEMI/ NSTEMI in 6 months) with a device specified as: Non reposponders or low responders after CRT-P/CRT-D or after ICD implantation (at least for 6 months)
- •3. Ischaemic or non-ischaemic chronic heart failure without any device.
- •4. Age: 18-80 years
- •5. LVEF<35%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 80
排除标准
- •SBP<100 Hgmm
- •AMI, stroke or life-threatening arrhytmia in the last 3 months
- •Multiorgan failure
- •Chronic kidney disease kreat >250
- •Severe COPD treated with steroid or more than 2 inh. therapy
- •Severe anaemia <100 mg/dl
- •GOT / GPT > 100 U/L
- •Any planned surgical event or TX
- •Non-consent or low compliant
- •Use of levosimendan in the patients’ history in the past 6 months
研究者
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