Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- concentration of high-sensitivity C-reactive protein (Hs-CRP )
研究概览
简要总结
The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis
详细描述
Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of response with ACE I/D polymorphisms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients < 16 years old
- •Patients who have been on regular HD for 6 months or longer
- •Hypertension at enrollment
排除标准
- •History of active connective tissue disease
- •Acute infection within 1 month prior to the study
- •Advanced liver disease
- •Gastrointestinal dysfunction requiring parental nutrition or active malignancy
- •Use of medications such as immunosuppressive drugs within 1 month prior to the study
- •Use of anti-inflammatory medications
- •Use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day
- •History of myocardial infarction or cerebrovascular event within 3 months prior to the study
- •History of ACE inhibitor-associated angioedema
- •Inability to discontinue ACE inhibitors or ARBs
研究组 & 干预措施
Ramipril
Ramipril, 2.5 mg daily, administered orally for 16 weeks
干预措施: Ramipril (Drug)
Placebo
Placebo, matched for the interventional drug, administered orally, daily for 16 weeks
干预措施: placebo (Drug)
结局指标
主要结局
concentration of high-sensitivity C-reactive protein (Hs-CRP )
时间窗: 16 weeks
marker of inflammation
concentration of Asymmetric dimethylarginine (ADMA)
时间窗: 16 weeks
marker of endothelial dysfunction
次要结局
未报告次要终点
研究者
Areej Mohamed Ateya
Assisstant lecturer
Ain Shams University