Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

August 10, 2011 updated by: Radboud University Medical Center
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
L-arginine treatment first, heme arginate treatment second
L-arginine first, heme arginate second three day treatment
Experimental: 2
Heme arginate treatment first, L-arginine treatment second
Heme arginate first, L-arginine second three day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenosine induced vasodilation
Time Frame: following a three day treatment with either heme arginate or L arginine
following a three day treatment with either heme arginate or L arginine

Secondary Outcome Measures

Outcome Measure
Time Frame
heme oxygenase expression and activity
Time Frame: assessed during and following a three day treatment with either heme arginate or L-arginine
assessed during and following a three day treatment with either heme arginate or L-arginine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • HOADO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerotic Cardiovascular Disease

Clinical Trials on L-arginine + heme arginate

Subscribe