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

This study has been completed.
Sponsor:
Information provided by:
Baker Heart Research Institute
ClinicalTrials.gov Identifier:
NCT00168467
First received: September 9, 2005
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Drug: Ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Baker Heart Research Institute:

Primary Outcome Measures:
  • 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:
  • Leg Blood Flow using Duplex Ultrasound

Estimated Enrollment: 40
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168467

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker Heart Research Institute
Investigators
Principal Investigator: Bronwyn A Kingwell, PhD Baker Heart Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00168467     History of Changes
Other Study ID Numbers: 20/03
Study First Received: September 9, 2005
Last Updated: January 28, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014