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

• Status: Unknown status
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: BioMarin Pharmaceutical

Criteria

Inclusion Criteria:

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

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 of severe 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