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

This study has been completed.

First Received: September 9, 2005 Last Updated: January 28, 2009 History of Changes

Sponsor:	Baker Heart Research Institute
Information provided by:	Baker Heart Research Institute
ClinicalTrials.gov Identifier:	NCT00168467

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

Resource links provided by NLM:

Drug Information available for: Ramipril

U.S. FDA Resources

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:

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

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:

Ahimastos AA, Lawler A, Reid CM, Blombery PA, Kingwell BA. Brief communication: ramipril markedly improves walking ability in patients with peripheral arterial disease: a randomized trial. Ann Intern Med. 2006 May 2;144(9):660-4. Summary for patients in: Ann Intern Med. 2006 May 2;144(9):I24.

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

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2009