Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Endothelial dysfunction evaluated on weeks 8 and 16.
研究概览
简要总结
The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.
详细描述
The effect of an 8-week treatment with either ramipril or placebo is studied using a randomized, double-blind, and crossover protocol. After given written informed consent, baseline characteristics including physical examination, ECG, blood sample and a noninvasive assessment of endothelial function are obtained. The patients are randomly assigned to receive either ramipril 10mg (up-titration-scheme: starting with 2.5mg in Week1, then 5mg in Week2 followed by 2-5mg for the final 6 weeks) followed by placebo or vice versa.The individual disease-modifying antirheumatic drug therapy is continued throughout the study. The examinations are repeated after 8 weeks treatment of the first and 8 weeks after the second study drug. At week 1 and 2 in each treatment period a safety visit is scheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
- •endothelial dysfunction (FMD < 4%, FMD:Flow-Mediated-Dilatation)
- •non-smokers
排除标准
- •previous myocardial infarction, coronary intervention or coronary surgery
- •previous treatment with statins in the last 6 months
- •previous treatment with ACE-inhibitors in the last 6 months
- •uncontrolled hypertension SAP/DAP > 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
- •dyslipidemia (LDL-cholesterol > 4.9 mmol)
- •normal CRP < 3 mg/l
- •overweight BMI > 35kg/m2
- •anaemia (hemoglobin < 10g/dl)
- •kidney disease (creatinine > 150 umol/l)
- •insulin-dependent diabetes mellitus
- •congestive heart failure (> NYHA I)
- •AV-Block>I
- •pregnancy
- •angio-edema
- •malignancy or chronic infection
- •drug abuse
结局指标
主要结局
Endothelial dysfunction evaluated on weeks 8 and 16.
次要结局
- Alteration of inflammatory parameters: C-reactive Protein, TNFa, Interleukin 6 on weeks 8 and 16.