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

Condition(s) targeted: Peripheral Arterial Disease

Intervention: Ramipril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Baker Heart Research Institute

Official(s) and/or principal investigator(s):
Bronwyn A Kingwell, PhD, Principal Investigator, Affiliation: Baker Heart Research Institute

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. We hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome:

Time to onset of claudication

Total exercise time during a standard treadmill test

Walking ability measured using the standard Walking Impairment Questionnaire

Secondary outcome: Leg Blood Flow using Duplex Ultrasound

Minimum age: N/A. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Alfred Hospital, Melbourne, Victoria 3004, Australia

Last updated: July 20, 2006