Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Endothelial function - Variation of Flow mediated dilation percentage
研究概览
简要总结
The aim of this study was to evaluate the effect of ramipril on the endothelial function and on the number of endothelial progenitor cells (EPCs) in systemic lupus erythematosus (SLE) patients.
详细描述
The early detection of additional risk factor for cardiovascular diseases (CVD) such as endothelial dysfunction and low number of EPC in SLE patients, and an intervention proven effective could reduce the cardiovascular morbidity and mortality. No study assessed the effect of ramipril on endothelial function and EPCs in SLE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •SLE according 1997 modified American College Rheumatology criteria
- •age older than 18 years
- •stable treatment for lupus for at least 3 months
排除标准
- •previous coronary artery disease
- •hypertension
- •dyslipidemia (LDL>149 mg/dL)
- •renal insufficiency (creatinine ≥1.4 mg/dL)
- •obesity (BMI≥30)
- •pregnancy
- •menopause
- •patients taking statins or angiotensin convertor enzyme inhibitor within the last 6 months
研究组 & 干预措施
ramipril group
Use of ramipril 10mg/day per 12 weeks
干预措施: Ramipril (Drug)
结局指标
主要结局
Endothelial function - Variation of Flow mediated dilation percentage
时间窗: 12 weeks
Patients were evaluated at baseline and after 12 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function
Number of endothelial progenitor cells (EPC)
时间窗: 12 weeks
Patients were evaluated at baseline and after 12 weeks. EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC) and by cell culture with quantification of colony formation units (CFUs).
次要结局
未报告次要终点
研究者
Emilia Inoue Sato
Full professor
Federal University of São Paulo