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

January 28, 2009 updated by: 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. The investigators hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Leg Blood Flow using Duplex Ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baker Heart Research Institute

Investigators

  • Principal Investigator: Bronwyn A Kingwell, PhD, Baker Heart Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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