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

A randomised phase IV study to examine the effects of ramipril on walking distance in patients with peripheral arterial disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000542695

Enrollment

Registered

2005-09-28

Start date

2006-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

Ramipril, 10 mg once daily (n=20) for 24 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Ankle-brachial index of <0.9 at rest in at least one legHistory of intermittent claudication (unilateral or bilateral) which was stable for 6 monthsEvidence of superficial femoral artery stenosis or occlusion on duplex scanBlood pressure <=160/90 mmHgStable medication regimen for at least 6 months and not previously treated with ACE inhibitors.

Exclusion criteria

Limiting coronary artery diseaseRenal failureHistory of hypertensionHistory of type 2 diabetes mellitus.

Outcome results