Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Phase 4

Terminated

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Drug: L-arginine + heme arginate; Drug: Heme arginate + L-arginine

• Registration Number: NCT00856817
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Status Verified: 2010-01
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	L-arginine + heme arginate	L-arginine treatment first, heme arginate treatment second
2	Heme arginate + L-arginine	Heme arginate treatment first, L-arginine treatment second

Primary Outcome Measures

Name	Time	Method
Adenosine induced vasodilation	following a three day treatment with either heme arginate or L arginine

Secondary Outcome Measures

Name	Time	Method
heme oxygenase expression and activity	assessed during and following a three day treatment with either heme arginate or L-arginine

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands