NCT00827775已完成4 期
Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Endothelial Progenitor Cells
研究概览
简要总结
- To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
- To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •on hemodialysis > 30 days
- •aged 18 to 80 years old
- •ability to provide informed consent
- •Primary nephrologist deems patient is at target dry weight
- •Predialysis SBP >140 or postdialysis SBP>130
排除标准
- •Patients with active wounds
- •Blood pressure unable to be measured by routine mechanisms in the upper extremity
- •Change in blood pressure medications in the previous 2 weeks
- •Intolerance of beta or alpha-blockers
- •pregnancy
- •Resting heart rate <50
- •Life expectancy < 6 months
- •Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)
研究组 & 干预措施
Intervention
Active Comparator
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions
干预措施: Carvedilol (Drug)
结局指标
主要结局
Endothelial Progenitor Cells
时间窗: 12 weeks
1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
次要结局
- Flow Mediated Vasodilation(12 weeks)
研究者
Peter Van Buren
Associate Professor of Medicine
University of Texas Southwestern Medical Center
研究点 (3)
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