EUCTR2013-000887-27-AT
Active, not recruiting
Phase 1
Pilot Trial: The effects of intravenous heme arginate on HO-1 expression and oxidative stress in the human heart - HO-1 in the Heart
DrugsNormosang
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medizinische Universität Wien
- Enrollment
- 31
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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