Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)

Last updated: August 6, 2008
Sponsor: University of Oxford
Overall Status: Trial Status Unknown

Phase

2

Condition

Chest Pain

Thrombosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00423280
06/Q1604/114
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the effect of 6R-BH4 on vascular function in patients with coronary artery disease. We hypothesize that 6R-BH4 will improve vascular function in these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (CABG)

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent

  • Female subject who is pregnant, lactating or planning pregnancy during course of study

  • Prior clinical diagnosis of heart failure requiring diuretic therapy with evidence ofsevere left ventricular dysfunction

  • Recent acute coronary event (<4 weeks)

  • Emergency CABG

  • Newly diagnosed diabetes mellitus (<1 month)

  • Body weight >130kg

  • Impaired renal function (creatinine >180umol/l)

  • Elevated liver function tests (ALT >50umol/l or AST >2x normal)

  • Pacemakers, ICDs or metallic implants not compatible with MRI scanning

  • Subjects receiving experimental medications or participating in another study

  • Terminally ill subjects

  • Known hypersensitivity to 6R-BH4

  • Concomitant treatment with methotrexate, levodopa, PDE-3 or PDE-5 inhibitors

Study Design

Total Participants: 66
Study Start date:
November 01, 2006
Estimated Completion Date:
February 28, 2009

Study Description

Decreased production of nitric oxide (NO) from the endothelium (the layer of cells that forms the lining of all blood vessels) has been shown to contribute to atherosclerosis. NO has multiple beneficial effects on vascular function. Endothelial function can be measured in humans via a number of methods, and endothelial dysfunction has been shown to be a strong adverse predictor of cardiovascular events and mortality.

Tetrahydrobiopterin (BH4) is essential for the production of NO in endothelial cells. 6R-BH4 is a synthetic version of naturally occurring BH4. We aim to investigate the effects of oral 6R-BH4 supplementation on endothelial function in patients with coronary artery disease.

Connect with a study center

  • Department of Cardiovascular Medicine, University of Oxford

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

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