Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
NCT02842424

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Led by University of Nebraska · Updated on 2025-05-23

70

Participants Needed

1

Research Sites

535 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The standard therapies for claudication include the medications cilostazol and pentoxifylline, supervised exercise therapy and operative revascularization. Recent data demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces improvements in the walking performance of patients with claudication that are higher than those of cilostazol and pentoxifylline and similar to those produced by supervised exercise therapy and operative revascularization. The mechanisms by which Ramipril therapy produces this impressive improvement in the functional capacity of claudicating patients remain unknown. The Investigators hypothesize that treatment of claudicating PAD patients with Ramipril will improve walking performance and quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the affected gastrocnemius.

CONDITIONS

Official Title

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A history of chronic claudication
  • Claudication confirmed by history and walking test observed by a vascular surgeon
  • Evidence of arterial blockage by ankle brachial index or imaging
  • Stable treatment for blood pressure, lipids, diabetes, and risk factors for at least 6 weeks
Not Eligible

You will not qualify if you...

  • Rest pain or tissue loss due to peripheral artery disease (Fontaine stage III or IV)
  • Recent acute lower limb ischemia from thromboembolism or trauma
  • Walking problems caused by other issues like joint, nerve, heart, or lung diseases
  • Current use of ACE inhibitors or angiotensin II receptor blockers
  • Severe kidney disease with estimated glomerular filtration rate below 30 ml/min/1.73 m2
  • History of severe narrowing of both renal arteries
  • History of angioedema or allergy related to ACE inhibitor treatment such as ramipril

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Medical Center

Omaha, Nebraska, United States, 68105

Actively Recruiting

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Research Team

H

Holly DeSpiegelaere

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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