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Clinical Trials/EUCTR2013-000887-27-AT
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

Medizinische Universität Wien0 sites31 target enrollmentApril 19, 2013

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.

Registry
who.int
Start Date
April 19, 2013
End Date
June 13, 2017
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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