Peripheral Artery Disease Clinical Trial
Official title:
Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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