A Randomised, Placebo-Controlled Study of Two Doses of Oral 6R-BH4 on Vascular Function in Subjects With Coronary Artery Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Vascular function using non-invasive magnetic resonance imaging (MRI).
研究概览
简要总结
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.
详细描述
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.
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
- Double (Participant, Investigator)
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
- •Multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (CABG)
排除标准
- •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
研究组 & 干预措施
1
700mg/day 6R-BH4
干预措施: 6R-BH4 (Drug)
2
400mg/day 6R-BH4
干预措施: 6R-BH4 (Drug)
3
Placebo
干预措施: 6R-BH4 (Drug)
结局指标
主要结局
Vascular function using non-invasive magnetic resonance imaging (MRI).
时间窗: Pre- and post- treatment with 6R-BH4 or placebo
次要结局
- Laboratory measures of vascular function.(At time of CABG surgery)