Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Flow Mediated Dilation
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent evidence indicates that COPD is associated with multiple systemic consequences including vascular endothelial dysfunction. Recently, it has been suggested that more patients with COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO) bioavailability resulting in vascular endothelial dysfunction in patients with COPD are important as endothelial dysfunction has been indicated to be an independent predictor of future atherosclerotic cardiovascular disease and events.
详细描述
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. In a previously funded grant, using a double blind, randomized experimental design, the investigators explored the effect of an acute dose of Kuvan or an antioxidant cocktail (1000mg of vitamin C, 600IU of vitamin E, and 600mg alpha-lipoic acid) on vascular health in patients with COPD. Consequently, the investigators found in separate experiments, that a single dose of both antioxidants and Kuvan transiently improves vascular health in patients with COPD. The current project is an attempt to expand on the investigator's previous findings and explore the effects of sub-chronic use of antioxidants and Kuvan on sustaining the improvements in vascular health in COPD.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with medically diagnosed COPD
- •apparently healthy controls
排除标准
- •FEV1/FVC >0.7 (normal lung function in patients only)
- •Clinical diagnosis of heart disease or diabetes
- •Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
- •uncontrolled high blood pressure
- •high blood pressure in your lungs
- •thyroid problems
- •Fluid in the lungs
- •Sleep apnea
- •Raynaud's Phenomenon
- •GI bleeding
- •Gangrene of the digits
- •History of low platelets or coagulopathies
- •Phenylketonuria (PKU)
- •Any allergy to Kuvan
研究组 & 干预措施
Tetrahydrobiopterin (BH4)
Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following 5mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.
干预措施: Tetrahydrobiopterin (BH4) (Drug)
Antioxidant Cocktail
Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.
干预措施: Antioxidant Cocktail (Dietary Supplement)
结局指标
主要结局
Change in Flow Mediated Dilation
时间窗: Change from Baseline and 12 weeks
Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment.
次要结局
- FEV1 %Predicted(Change from Baseline and 12 weeks)
- Percent of ACH to Heat Max(Change from Baseline and 12 weeks)
- Change in PWV (Pulse Wave Velocity)(Change from Baseline and 12 weeks)
研究者
Ryan Harris
Principal Investigator
Augusta University