NCT00168467

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

September 9, 2005

Last Update Submit

January 28, 2009

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

  • Time to onset of claudication

  • Total exercise time during a standard treadmill test

  • Walking ability measured using the standard Walking Impairment Questionnaire

Secondary Outcomes (1)

  • Leg Blood Flow using Duplex Ultrasound

Interventions

RamiprilDRUG

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Limiting coronary artery disease
  • Renal Failure
  • History of hypertension
  • History of type 2 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

  • 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. doi: 10.7326/0003-4819-144-9-200605020-00009.

    PMID: 16670135RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ramipril

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

AU(1)