Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856817
Recruitment Status : Terminated (Recruitment faillure. Similar study published by others. Not yet entered treatment phase.)
First Posted : March 6, 2009
Last Update Posted : August 11, 2011
Dutch Diabetes Research Foundation
Information provided by:
Radboud University

Brief Summary:
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: L-arginine + heme arginate Drug: Heme arginate + L-arginine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
L-arginine treatment first, heme arginate treatment second
Drug: L-arginine + heme arginate
L-arginine first, heme arginate second three day treatment

Experimental: 2
Heme arginate treatment first, L-arginine treatment second
Drug: Heme arginate + L-arginine
Heme arginate first, L-arginine second three day treatment

Primary Outcome Measures :
  1. Adenosine induced vasodilation [ Time Frame: following a three day treatment with either heme arginate or L arginine ]

Secondary Outcome Measures :
  1. heme oxygenase expression and activity [ Time Frame: assessed during and following a three day treatment with either heme arginate or L-arginine ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • at least 18 and no older than 65 on the day of first dosing
  • healthy
  • Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
  • In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.

Exclusion Criteria:

  • Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
  • history of smoking within the past year
  • history of or current abuse of drugs, alcohol and/or solvents
  • Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
  • Inability to understand the nature and extent of the trial and the procedures required
  • Participation to a drug trial within 60 days prior to the first dose
  • Febrile illness within 3 days before the first dose
  • Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00856817

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
Dutch Diabetes Research Foundation

Responsible Party: P. Smits, Radboud University Nijmegen Medical Centre Identifier: NCT00856817     History of Changes
Other Study ID Numbers: HOADO
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases