Ischemia-reperfusion InjuryPhase 2NCT01461512

Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

A Phase 2 study testing heme arginate administration in people with Ischemia-reperfusion Injury, run by MWolzt at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 46 years, men onlyHealthy volunteers can take part
Conditions the study is for: Ischemia-reperfusion Injury
What is being tested?: heme arginate administration
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteAustria
Study dates: Jan 2009to Dec 2011
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 46 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna, Department of Clinical Pharmacology
Vienna, 1090

Other trials in Austria

About this study

Official title: The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia

Read the detailed 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.

Conditions: Ischemia-reperfusion Injury
Being tested: heme arginate administration, Placebo administration
Medical subject headings: Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

heme arginate administrationDrug
heme arginate 1 mg/kg body weight 24 hours prior to ischemia
Placebo administrationDrug
NaCl isotonic

Study groups in NCT01461512
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo administration
Heme arginate treatment	Experimental	Not described Receives: Drug: heme arginate administration

What is being measured

The primary outcome is the main question the study is designed to answer.

BOLD MRI signal
functional MRI assessment of blood oxygen level dependent signal strength
Measured: 2 minutes prior to ischemia till 25 minutes after ischemia
Serum markers of myocellular injury
(myoglobin, creatine-kinase)
Measured: 24 hours after ischemia

Secondary outcomes (2)

Blood pressure
in mmHg
Measured: 20 minutes prior to and 40 minutes after ischemia
Heart rate
in beats per minute
Measured: prior to and after ischemia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2011

First posted28 Oct 2011 (estimated)
Study startJan 2009
Primary completionAug 2011
Study completionDec 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemia-reperfusion InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01461512
Sponsor's protocol ID: Version 1.2 2008-006967-35
Status last verified: Oct 2011
First submitted: 14 Oct 2011
Last updated: 28 Oct 2011
Results posted: No
Data monitoring committee: Yes

Publications

Andreas M, Schmid AI, Doberer D, Schewzow K, Weisshaar S, Heinze G, Bilban M, Moser E, Wolzt M. Heme arginate improves reperfusion patterns after ischemia: a randomized, placebo-controlled trial in healthy male subjects. J Cardiovasc Magn Reson. 2012 Aug 2;14(1):55. doi: 10.1186/1532-429X-14-55.
PubMed 22857721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemia-reperfusion Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia
ClinicalTrials.gov ID: NCT01461512
Acronym / sponsor ID: Version 1.2 2008-006967-35
Conditions: Ischemia-reperfusion Injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 16 participants (actual)
Lead sponsor: MWolztUniversity, hospital or other
Study start: Jan 2009
Primary completion: Aug 2011 (actual)
Study completion: Dec 2011 (estimated)
First posted: 28 Oct 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

As additional outcome, levels of myoglobin and creatine-kinase will be measured in plasma according to standard laboratory procedures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo administration
Heme arginate treatment	Experimental	Drug: heme arginate administration

Who may qualify

Ages: 18 to 46 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
heme arginate administrationheme arginate 1 mg/kg body weight 24 hours prior to ischemia	Drug	Heme arginate treatment
Placebo administrationNaCl isotonic	Drug	Placebo

Primary outcome

BOLD MRI signal
Time frame: 2 minutes prior to ischemia till 25 minutes after ischemia
functional MRI assessment of blood oxygen level dependent signal strength
Serum markers of myocellular injury
Time frame: 24 hours after ischemia
(myoglobin, creatine-kinase)

2 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
Derived from this study: PubMed 22857721Andreas M, Schmid AI, Doberer D, Schewzow K, Weisshaar S, Heinze G, Bilban M, Moser E, Wolzt M. Heme arginate improves reperfusion patterns after ischemia: a randomized, placebo-controlled trial in healthy male subjects. J Cardiovasc Magn Reson. 2012 Aug 2;14(1):55. doi: 10.1186/1532-429X-14-55.

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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing heme arginate administration in people with Ischemia-reperfusion Injury, run by MWolzt at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD MRI signal (time frame: 2 minutes prior to ischemia till 25 minutes after ischemia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461512, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.