A pilot trial to improve the medical protection of the heart from injury due to reduced blood flow

Pilot Trial: The effects of intravenous heme arginate on HO-1 expression and oxidative stress in the human heart - HO-1 in the Heart

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000887-27-AT

Enrollment

Registered

2013-04-19

Start date

2013-05-23

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemia reperfusion injury MedDRA version: 14.1 Level: LLT Classification code 10055224 Term: Cardiac ischemia System Organ Class: 100000004849 MedDRA version: 14.1 Level: LLT Classification code 10023031 Term: Ischemia coronary artery origin System Organ Class: 100000004849 MedDRA version: 14.1 Level: LLT Classification code 10023033 Term: Ischemia myocardial System Organ Class: 100000004849

Interventions

Trade Name: Normosang Product Name: Normosang Product Code: 1–27260 Pharmaceutical Form: Infusion INN or Proposed INN: Normosang CAS Number: 100438-92-4 Other descriptive name: HEME ARGINATE Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent - Men and women aged between 40 and 85 years (inclusive) - Body mass index =65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

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 45mmHg - Acute or recent (<7 days) myocardial infarction

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To evaluate the effects of heme arginate administration in two different doses on myocardial HO – 1 induction ;Secondary Objective: 2) To evaluate postoperative plasma levels of myoglobin, creatin-kinase, troponin T and reactive oxygen species according to treatment period. ;Primary end point(s): Main outcome variables HO – 1 mRNA and protein induction in the heart due to heme arginate pretreatment;Timepoint(s) of evaluation of this end point: during surgery	—

Measure

Time frame

Main Objective: 1) To evaluate the effects of heme arginate administration in two different doses on myocardial HO – 1 induction ;Secondary Objective: 2) To evaluate postoperative plasma levels of myoglobin, creatin-kinase, troponin T and reactive oxygen species according to treatment period. ;Primary end point(s): Main outcome variables HO – 1 mRNA and protein induction in the heart due to heme arginate pretreatment;Timepoint(s) of evaluation of this end point: during surgery

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Secondary

Measure	Time frame
Secondary end point(s): HO – 1 mRNA and protein induction in PMBC in patients undergoing cardiac surgery due to heme arginate pretreatment Evaluate dose-response of HO-1 induction in the heart Additional outcome Reactive oxygen species levels (Biopsies and blood samples) Postoperative plasma levels of creatine kinase, troponin T and myoglobin Safety variables Major cardiac adverse events;Timepoint(s) of evaluation of this end point: until 72 hours after surgery	—

Measure

Time frame

Secondary end point(s): HO – 1 mRNA and protein induction in PMBC in patients undergoing cardiac surgery due to heme arginate pretreatment Evaluate dose-response of HO-1 induction in the heart Additional outcome Reactive oxygen species levels (Biopsies and blood samples) Postoperative plasma levels of creatine kinase, troponin T and myoglobin Safety variables Major cardiac adverse events;Timepoint(s) of evaluation of this end point: until 72 hours after surgery

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Countries

Austria

Contacts

Public ContactProf. Dr. Alfred Kocher

Medical University of Vienna

alfred.kocher@meduniwien.ac.at00431404006966

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026