EUCTR2013-000887-27-AT进行中(未招募)1 期
Pilot Trial: The effects of intravenous heme arginate on HO-1 expression and oxidative stress in the human heart - HO-1 in the Heart
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 31
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
- •-Signed informed consent
- •-Men and women aged between 40 and 85 years (inclusive)
- •-Body mass index <35 kg/m2
- •-Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •-Known hypersensitivity to the study drug or any excipients of the drug formulation
- •-Treatment with another investigational drug within 3 weeks prior to screening
- •-History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
- •-Severe renal failure (glomerula filtration rate < 30ml/min)
- •-Moderately or severe impaired left ventricular function (ejection fraction < 40%)
- •-Moderately or severe impaired right ventricular function
- •-Systolic pulmonary pressure > 45mmHg
- •-Acute or recent (<7 days) myocardial infarction
研究者
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