Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group
研究概览
简要总结
Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.
详细描述
The main purpose of this research study is to conduct a research study to determine if Sildenafil compared to placebo will improve the vascular health of arteries and veins before arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and increase in blood flow after fistula creation. An arteriovenous fistula (shunt) is a connection between the artery and vein in the arm for dialysis use. Another purpose of this study is to determine if Sildenafil reduces the blood and tissue levels of oxidants prior to fistula creation. Oxidants are harmful substances in the body that damage the cells tissues, and organs.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years of age male or female
- •Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery
排除标准
- •Patient currently on nitrate therapy or any nitric oxide donor in any form
- •Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
- •Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg.
- •Patient life expectancy < nine months.
- •Patient unable or unwilling to meet study requirements.
研究组 & 干预措施
Sildenafil
20 mg twice a day orally
干预措施: Sildenafil (Drug)
Placebo
Placebo twice a day orally
干预措施: Placebo (Other)
结局指标
主要结局
Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group
时间窗: 2 weeks
For flow mediated dilation studies (FMD), the brachial artery diameter was measured by ultrasound at baseline. An automated floor pressure cuff was inflated on the upper arm to a suprasystolic pressure that was sustained for 5 minutes, and the brachial diameter measurement was repeated 55-65 seconds after releasing the cuff. FMD was calculated as the percentage change in arterial diameter from baseline. For venous occlusion plethysmography studies (VP), forearm volume was measured using a strain-gauge plethysmography device during application of an upper arm BP cuff at increasing but subsystolic pressures. Venous capacitance slope was estimated from the volume-pressure relationship and expressed as a percentage increase in volume per millimeters of mercury. The change at baseline and 2 weeks in these measurements between the sildenafil and placebo group will be assessed.
次要结局
- Number of Participants With a Change in Blood Flow Rate(6 weeks)
研究者
Timmy Lee, MD
Principal investigator
University of Alabama at Birmingham