The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
研究概览
简要总结
In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration.
Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 year
- •polyarthritis
- •DAS score > 2.5
排除标准
- •previous use of MTX
- •concomitant use of dipyridamole/sulfazalasine
- •Alcohol > 21 U/week
- •elevated liver enzymes
- •pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia
结局指标
主要结局
Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
次要结局
- Adenosine deaminase activity
- CRP, BSE, DAS