Angiotensin Converting Enzyme (ACE) Inhibition and Peripheral Arterial Disease

NCT00681226 | Completed Phase 4

• 1 other identifier: 273/06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our preliminary findings indicate that the drug ramipril is much more effective in improving walking ability than current therapies. To be accepted as a new treatment for PAD these findings require validation in a much larger clinical trial.We propose to examine the effects of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If positive, this study will identify ramipril as a potential new therapy for PAD.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; angiotensin converting enzyme inhibitors; exercise

Outcome Measures

Primary Outcomes (1)

• walking time

  baseline and 6 months

Secondary Outcomes (1)

• walking impairment questionnaire

  baseline and 6 months

Interventions

Ramipril or matching placebo DRUG

10 mg Ramipril or matching placebo once daily for 6 months

Also known as: Ramace

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle brachial index of \<0.9 in at least one leg
• History of intermittent claudication (unilateral or bilateral)
• A stable medication regimen for at least 6 months

You may not qualify if:

• Limiting coronary artery disease
• Renal failure (serum creatinine \> 0.20 mmol/L)
• Current treatment or treatment within the previous 6 months with ACE inhibitors or angiotensin II receptor antagonists

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Baker Heart Research Institute

Melbourne, Victoria, 8008, Australia

Location

Related Publications (3)

• 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: 16670135 BACKGROUND

• Ahimastos AA, Latouche C, Natoli AK, Reddy-luthmoodoo M, Golledge J, Kingwell BA. Potential vascular mechanisms of ramipril induced increases in walking ability in patients with intermittent claudication. Circ Res. 2014 Mar 28;114(7):1144-55. doi: 10.1161/CIRCRESAHA.114.302420. Epub 2014 Jan 7.

  PMID: 24397981 DERIVED

• Ahimastos AA, Walker PJ, Askew C, Leicht A, Pappas E, Blombery P, Reid CM, Golledge J, Kingwell BA. Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial. JAMA. 2013 Feb 6;309(5):453-60. doi: 10.1001/jama.2012.216237.

  PMID: 23385271 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bronwyn A Kingwell, PhD

  Baker Heart Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 21, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

AU (1)