The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart
Myocardial Ischemia
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring carboxyhemoglobin, neutrophil, reactive oxygen species, reperfusion injury
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
Exclusion criteria (any of the following):
- 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 < 30 ml/min)
- Moderately or severe impaired left ventricular function (ejection fraction < 40%)
- Moderately or severe impaired right ventricular function
- Systolic pulmonary pressure > 45 mmHg
- Acute or recent (<7 days) myocardial infarction
- Child bearing potential
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Heme arginate (high dose)
Heme arginate (low dose)
Placebo
24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 3 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
24 hours prior to the planned surgical aortic valve replacement, heme arginate at a dose of 1 mg/kg diluted to 110ml with 0.9% sodium chloride was administered at a single intravenous infusion using an infusion pump.
24 hours prior to the planned surgical aortic valve replacement, subjects received a single intravenous infusion of an equivalent volume of 0.9% sodium chloride solution.