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Completed

NCT Number: NCT00168467

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramipril

Drug

Primary outcomes

  1. Time to onset of claudication

  2. Total exercise time during a standard treadmill test

  3. Walking ability measured using the standard Walking Impairment Questionnaire

Secondary outcomes

  1. Leg Blood Flow using Duplex Ultrasound

Sponsors and collaborators

Lead sponsor

Baker Heart Research Institute

Other

Registry information

Important dates

First posted
Sep 15, 2005
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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