Allopurinol as a possible oxygen sparing agent during exercise in peripheral arterial disease

Not Applicable

Completed

Conditions: Peripheral arterial disease
Other peripheral vascular diseases
Circulatory System

Registration Number: ISRCTN01772998

Lead Sponsor: niversity of Dundee (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Men and women age 35-85 years suffering from PAD. PAD will be defined as:
1.1. Claudication defined as leg pain on walking and disappearing within 10 minutes on standing and of presumed atherosclerotic origin
1.2. An ankle brachial pressure index (ABPI) of <0.90 on the worst leg at rest
2. Stable disease demonstrated by having a reproducible pain free walking distance on 2 consecutive treadmill tests, i.e. less than 25% variance. The reason for termination of the test must be claudication pain only. All treadmill tests will be done at a speed of 3.2 km/h (= 2 mph), as is standard practice in PAD trials. The incline will begin at 0% and increase in grade of 2% every 2 minutes. This is the standard Skinner-Gardner protocol (Angiology 1992, 43(8): 661-671).

Exclusion Criteria

1. Rest pain
2. Childbearing potential
3. Heart failure
4. Any other exercise limiting cardiac disease
5. BP >180/100 mHg
6. eGFR <60 ml/min
7. Liver disease
8. Malignancy
9. Already on allopurinol or had an adverse reaction to it.
10. Participants who have had a recent marked change in symptoms or recent (in the last six months) intervention for PAD
11. Participants receiving treatment which is contraindicated with the study treatment
11.1. 6-mercaptopurine
11.2. Azathioprine
11.3. Warfarin
11.4. Theophylline

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distance to onset of claudication pain at 24 weeks but we will also measure total exercise distance.

Secondary Outcome Measures

Name	Time	Method
1. To see if allopurinol improves quality of life in participants with PAD<br>2. To investigate the anti-oxidant effects of allopurinol of participants with PAD