Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- ANKLE BRACHIAL INDEX
研究概览
简要总结
The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less than 0.9 was about 15~30% in patients with end stage renal disease (ESRD), which was higher than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis respectively. In addition, baPWV>2,100 cm/s was shown to be related to potential PAD. ABI <0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and our previous study has demonstrated that far infrared (FIR) therapy can improve access flow and unassisted patency of atrioventricular (AV) fistula.
The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related to endothelial dysfunction in HD patients.
详细描述
In this study, 300 HD patients will be enrolled to receive ABI and baPWV and about 90 patients (30% according to the literature review) who have abnormal ABI (<0.9) or baPWV (>2100 cm/sec) will be randomly allocated to FIR group (receiving FIR therapy for 40 minutes thrice weekly) and control group (without FIR therapy). In patients with abnormal ABI or baPWV, the effect of single or one-year treatment of FIR on the following items will be studied: (1) ABI, (2) baPWV and (3) markers related to endothelial dysfunction [including low and high density lipoprotein cholesterol (LDL and HDL), asymmetric dimethylarginine (ADMA), hypersensitive C-reactive protein (hsCRP), matrix metalloproteinase-9 (MMP-9)]. The effect of FIR on PAD or cardiovascular events during one year of follow-up will also be studied.
This study will allow us to identify the frequency of and the risk factors associated with abnormal ABI & PWV as well as the effect of single or one-year FIR therapy on ABI & PWV in HD patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In this study, we will include 300 patients who have received 4 hours of maintenance HD therapy three times weekly for at least 3 months
排除标准
- •Patients with life expectancy less than 1 year
- •Patients with history of active malignancy
结局指标
主要结局
ANKLE BRACHIAL INDEX
时间窗: One year
The values of the ABI were measured 10 to 30 min before HD. The ABIs will be measured by using an ABI-form device (VP1000,Colin, Komaki, Japan). The ABI will be calculated by the ratio of the ankle systolic BP divided by the arm systolic BP. The systolic BP of the arm without dialysis access and the value of the ankle systolic BP will be used for the calculation. All of the ABI and PWV will be measured twice. If the difference between them was more than 10%, a third measurement was done. The mean of the two closest values was recorded into our data base.
次要结局
- Markers of endothelial function(One year)
- PAD or cardiovascular events(one year)