The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

Baker Heart Research Institute

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT00168467

20/03

Details and patient eligibility

About

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.

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind