The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
研究概览
简要总结
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).
Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •end stage renal disease
- •>18 years
- •chronic intermittent hemodialysis
排除标准
- •acute Infection
- •acute renal failure
- •heart failure (NYHA IV)
- •pregnancy
结局指标
主要结局
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
时间窗: 30 days
To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD
次要结局
未报告次要终点
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology
Heinrich-Heine University, Duesseldorf