Overview

This trial is active, not recruiting.

Condition ischemia-reperfusion injury
Treatments heme arginate administration, placebo administration
Phase phase 2
Sponsor MWolzt
Start date January 2009
End date August 2011
Trial size 16 participants
Trial identifier NCT01461512, Version 1.2 2008-006967-35

Summary

Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1 induction during short-time ischemia in skeletal muscle of healthy subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo administration
NaCl isotonic
(Experimental)
heme arginate administration
heme arginate 1 mg/kg body weight 24 hours prior to ischemia

Primary Outcomes

Measure
BOLD MRI signal
time frame: 2 minutes prior to ischemia till 25 minutes after ischemia
Serum markers of myocellular injury
time frame: 24 hours after ischemia

Secondary Outcomes

Measure
Blood pressure
time frame: 20 minutes prior to and 40 minutes after ischemia
Heart rate
time frame: prior to and after ischemia

Eligibility Criteria

Male participants from 18 years up to 46 years old.

Inclusion Criteria: - Signed informed consent - Men aged between 18 and 46 years (inclusive) - Nonsmoker for more than 3 months - Body mass index between 18 and 27 kg/m2 - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Negative results from urine drug screen if performed - Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study Exclusion Criteria: - Known hypersensitivity to the study drug or any excipients of the drug formulation - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study - 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 - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug including over-the-counter drugs (including herbal medicines such as St John's Wort) - Symptoms of a clinically relevant illness in the 2 weeks before the first study day - Blood donation during the previous 3 weeks - Any metallic, electric, electronic or magnetic device or object not removable - Claustrophobia

Additional Information

Official title The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia
Description Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. The investigators previous data confirmed strong HO-1 induction following heme arginate infusion in healthy humans. Therefore, the investigators next approach is to evaluate the direct effects of heme arginate on short time Ischemia-reperfusion (IR) injury in healthy humans. This will be done by the following surrogate markers of IR injury. Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) can measure alterations in tissue oxygenation in a high spatial and temporal resolution. This non-invasive methods therefore represent a promising technique to evaluate the effects of HO-1 induction on energy metabolism and oxygen saturation during ischemic stress and short time reperfusion in skeletal muscle. As additional outcome, levels of myoglobin and creatine-kinase will be measured in plasma according to standard laboratory procedures.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Medical University of Vienna.