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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
Sponsor:
Information provided by (Responsible Party):
Martin Andreas, M.D., Medical University of Vienna

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo 24h prior surgery
Drug: placebo
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



Primary Outcome Measures :
  1. HO - 1 mRNA and protein induction in the heart due to heme arginate pretreatment [ Time Frame: 24h after administration ]
  2. HO - 1 mRNA and protein induction in PMBC in patients undergoing cardiac surgery due to heme arginate pretreatment [ Time Frame: 24h after surgery ]
  3. Evaluate dose-response of HO-1 induction in the heart [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Reactive oxygen species levels (Biopsies and blood samples) [ Time Frame: 24 hours after administration ]
  2. Postoperative plasma levels of creatine kinase, troponin T and myoglobin [ Time Frame: 72 hours after surgery ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 will exclude a subject from the study:

  • 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

Information from the National Library of Medicine

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


Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Martin Andreas, MD, PhD    004314040069660    martin.andreas@meduniwien.ac.at   
Sponsors and Collaborators
Martin Andreas, M.D.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Andreas, M.D., MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02314780     History of Changes
Other Study ID Numbers: HO-1 in the Heart
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes