Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Atherosclerotic Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00856817
• Other study ID #: HOADO
• Status: Terminated
• Phase: Phase 4
• First received: March 5, 2009
• Last updated: August 10, 2011
• Start date: March 2009

Study information

• Verified date: January 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• L-arginine + heme arginate
L-arginine first, heme arginate second three day treatment
• Heme arginate + L-arginine
Heme arginate first, L-arginine second three day treatment

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenosine induced vasodilation		following a three day treatment with either heme arginate or L arginine	No
Secondary	heme oxygenase expression and activity		assessed during and following a three day treatment with either heme arginate or L-arginine	No