Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

MWolzt

Status and phase

Unknown

Phase 2

Conditions

Ischemia-reperfusion Injury

Treatments

Drug: heme arginate administration

Drug: Placebo administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01461512

Version 1.2 2008-006967-35

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

Male

Ages

18 to 46 years old

Volunteers

Accepts Healthy Volunteers

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