Pilot Trial: The Effects of Intravenous Heme Arginate on HO-1 Expression and Oxidative Stress in the Human Heart
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|ClinicalTrials.gov Identifier: NCT02314780|
Recruitment Status : Unknown
Verified March 2016 by Martin Andreas, M.D., Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : December 11, 2014
Last Update Posted : March 16, 2016
Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy humans5. Furthermore, we could demonstrate the amelioration of experimental ischemia reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured by functional MRI6.
Therefore, we propose that HO-1 induction in the human heart may be a suitable target to mitigate cardiac ischemia-reperfusion injury.
The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and after aortic cross clamping in subjects with or without preceding heme arginate treatment in two different dosages. The HO-1 expression will also be measured in the clinical trials in peripheral blood mononuclear cells. As additional outcome, levels of myoglobin, creatine-kinase and troponin T and reactive oxygen species will be measured in plasma according to standard laboratory procedures.
|Condition or disease||Intervention/treatment||Phase|
|Ischemia||Drug: heme arginate 1mg/kg Drug: heme arginate 3mg/kg Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2017|
Placebo Comparator: Placebo
Placebo 24h prior surgery
Active Comparator: Treatment cohort A
heme arginate 1mg/kg 24h prior surgery
Drug: heme arginate 1mg/kg
Active Comparator: Treatment cohort B
heme arginate 3mg/kg 24h prior surgery
Drug: heme arginate 3mg/kg
- HO - 1 mRNA and protein induction in the heart due to heme arginate pretreatment [ Time Frame: 24h after administration ]
- HO - 1 mRNA and protein induction in PMBC in patients undergoing cardiac surgery due to heme arginate pretreatment [ Time Frame: 24h after surgery ]
- Evaluate dose-response of HO-1 induction in the heart [ Time Frame: 24 hours after surgery ]
- Reactive oxygen species levels (Biopsies and blood samples) [ Time Frame: 24 hours after administration ]
- Postoperative plasma levels of creatine kinase, troponin T and myoglobin [ Time Frame: 72 hours after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314780
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Martin Andreas, MD, PhD 004314040069660 email@example.com|