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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Flow mediated dilatation (FMD)
研究概览
简要总结
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.
详细描述
Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
R
Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
干预措施: folic acid, vitamin B12 and B6 and rosuvastatin (Drug)
V
Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin
干预措施: folic acid, vitamin B12 and B6 and rosuvastatin (Drug)
结局指标
主要结局
Flow mediated dilatation (FMD)
时间窗: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
次要结局
- changes in biochemistry parameters(after 6 weeks of randomized treatment and after 6 weeks of combined treatment)