The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Phase 4
Completed
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT00168467
- Lead Sponsor
- Baker Heart Research Institute
- Brief Summary
One important clinical challenge in older individuals is maintaining mobility in the absence of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality of life due to intermittent claudication causing pain and limiting mobility.
Conventional therapies have only modest effect in improving symptoms. The investigators hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Ankle-brachial index of <0.9 at rest in at least one leg
- History of intermittent claudication (unilateral or bilateral) which was stable for 6 months
- Evidence of superficial femoral artery stenosis or occlusion on duplex scan
- Blood pressure <=160/90 mmHg
- Stable medication regimen for at least 6 months and not previously treated with ACE inhibitors
Exclusion Criteria
- Limiting coronary artery disease
- Renal Failure
- History of hypertension
- History of type 2 diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to onset of claudication Total exercise time during a standard treadmill test Walking ability measured using the standard Walking Impairment Questionnaire
- Secondary Outcome Measures
Name Time Method Leg Blood Flow using Duplex Ultrasound
Trial Locations
- Locations (1)
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia