Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
VA Medical Center
Omaha, Nebraska, United States, 68105
Actively Recruiting
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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