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临床试验/EUCTR2018-001623-39-AT
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:
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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

发起方
Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)

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