EUCTR2018-001623-39-AT进行中(未招募)1 期
Assessment of body composition changes after Levosimendan treatment in patients with advanced heart failure - BCC - LEVO
Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)0 个研究点目标入组 40 人开始时间: 2018年5月4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
- 入组人数
- 40
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.Male / female, = 18 to = 85 years of age at baseline study visit
- •2.Written informed consent
- •3.Advanced heart failure:
- •a.Reduced LVEF
- •b.NYHA II-IV
- •c.NT-proBNP = 125 ng/l
- •d.Standard of Care heart failure treatment (ACE inhibitor + ß-blocker , if tolerated)
- •e.Chronic heart failure (SoC heart failure treatment > 30 days)
- •4.Admitted for levosimendan treatment (interventional group) / no levosimendan treatment (control group)
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Age =18 or = 85 years of age at baseline study visit
- •2.History of alcohol or drug addiction in the last 12 months
- •3.Pregnancy or breastfeeding
- •4.Subject unable to comply with follow up visits
- •5.Inability to give informed consent
- •6.Allergy or hypersensitivity to levosimendan
研究者
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