NCT01461512

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

2.6 years

First QC Date

October 14, 2011

Last Update Submit

October 26, 2011

Conditions

Ischemia-reperfusion Injury

Outcome Measures

Primary Outcomes (2)

  • BOLD MRI signal

    functional MRI assessment of blood oxygen level dependent signal strength

    2 minutes prior to ischemia till 25 minutes after ischemia

  • Serum markers of myocellular injury

    (myoglobin, creatine-kinase)

    24 hours after ischemia

Secondary Outcomes (2)

  • Blood pressure

    20 minutes prior to and 40 minutes after ischemia

  • Heart rate

    prior to and after ischemia

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo administration

Heme arginate treatment

EXPERIMENTAL
Drug: heme arginate administration

Interventions

heme arginate administrationDRUG

heme arginate 1 mg/kg body weight 24 hours prior to ischemia

Heme arginate treatment
Placebo administrationDRUG

NaCl isotonic

Placebo

Eligibility Criteria

Age18 Years - 46 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 22857721DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Michael Wolzt

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 28, 2011

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

AU(1)