Using Ramipril to Improve Walking in Patients with Claudication

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

This study is testing if the medication Ramipril can help people with leg pain from peripheral artery disease walk better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Nebraska (Academic / other)
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT02842424 on ClinicalTrials.gov

What this trial studies

This interventional study focuses on patients with peripheral artery disease (PAD) who experience claudication, a condition characterized by pain in the legs during walking. The study aims to investigate how Ramipril, an angiotensin-converting enzyme (ACE) inhibitor, enhances walking performance by examining changes in muscle fiber structure and biochemistry, as well as the effects on small blood vessels and tissue oxygenation. The research will also explore the cellular mechanisms involved in Ramipril's action on arterial smooth muscle cells. By understanding these mechanisms, the study hopes to provide insights into effective treatments for claudication.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with chronic claudication due to peripheral artery disease who have stable medical conditions.

Not a fit: Patients with severe claudication symptoms, such as rest pain or tissue loss, or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from claudication, enhancing their walking ability and overall quality of life.

How similar studies have performed: Previous studies have shown promising results with Ramipril in improving walking performance in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. A positive history of chronic claudication,
2. Exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon,
3. Arterial occlusive disease per ankle Brachial index measurements and/or other imaging modalities,
4. Stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.

Exclusion Criteria:

1. Rest pain or tissue loss due to PAD (Fontaine stage III and IV),
2. acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
3. Walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology,
4. Current use of either ACE inhibitors or angiotensin II receptor blockers,
5. Chronic kidney disease with estimated Glomerular Filtration Rate \< 30 ml/min/1.73 m2,
6. History of bilateral severe renal artery stenosis and 7) History of angioedema related to previous ACE-inhibitor treatment or known hypersensitivity to ramipril or other ACE inhibitors.

Where this trial is running

Omaha, Nebraska

• VA Medical Center — Omaha, Nebraska, United States (Recruiting)

Study contacts

• Principal investigator: Iraklis I Pipinos, MD — University of Nebraska
• Study coordinator: Holly DeSpiegelaere

Conditions Peripheral Arterial Disease; Ramipril; Angiotensin-converting enzyme; Claudication; Myopathy