Clinical trial NCT01095549: Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients
Official title: Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Artery Disease
Keywords: ankle-brachial index (ABI)
brachial-ankle pulse wave velocity (baPWV)
far infrared therapy (FIR)
hemodialysis (HD)
peripheral artery disease (PAD)
Peripheral artery disease in hemodialysis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2010-03-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with life expectancy less than 1 year
* Patients with history of active malignancy

Primary outcomes:
measure: ANKLE BRACHIAL INDEX
timeFrame: One year
Secondary outcomes:
measure: Markers of endothelial function
timeFrame: One year
measure: PAD or cardiovascular events
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chih-Ching Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: