Back to resultsHeme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Primary Purpose
Atherosclerotic Cardiovascular Disease
Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
L-arginine + heme arginate
Heme arginate + L-arginine
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerotic Cardiovascular Disease
Eligibility Criteria
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
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
L-arginine treatment first, heme arginate treatment second
Heme arginate treatment first, L-arginine treatment second
Outcomes
Primary Outcome Measures
Adenosine induced vasodilation
Secondary Outcome Measures
heme oxygenase expression and activity
Full Information
NCT ID
NCT00856817
First Posted
March 5, 2009
Last Updated
August 10, 2011
Sponsor
Radboud University Medical Center
Collaborators
Dutch Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00856817
Brief Title
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
Recruitment faillure. Similar study published by others. Not yet entered treatment phase.
Study Start Date
March 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Diabetes Research Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
L-arginine treatment first, heme arginate treatment second
Arm Title
2
Arm Type
Experimental
Arm Description
Heme arginate treatment first, L-arginine treatment second
Intervention Type
Drug
Intervention Name(s)
L-arginine + heme arginate
Intervention Description
L-arginine first, heme arginate second three day treatment
Intervention Type
Drug
Intervention Name(s)
Heme arginate + L-arginine
Intervention Description
Heme arginate first, L-arginine second three day treatment
Primary Outcome Measure Information:
Title
Adenosine induced vasodilation
Time Frame
following a three day treatment with either heme arginate or L arginine
Secondary Outcome Measure Information:
Title
heme oxygenase expression and activity
Time Frame
assessed during and following a three day treatment with either heme arginate or L-arginine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
We'll reach out to this number within 24 hrs