Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

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

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Folic Acid; Hydroxocobalamin; Pyridoxal; Pyridoxine; Rosuvastatin Calcium; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago

• history of percutaneous coronary intervention (PTCA or stenting)

• confirmed consent

Exclusion Criteria:

• myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago

• ongoing treatment with statins

• ongoing vitamin supplementation with folic acid and B vitamins

• <18 years

• active smokers

• uncontrolled arterial hypertension

• renal insufficiency

• atrial fibrillation

• liver disease

• NYHA class >2

• familial hypercholesterolemia