Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Launched by UNIVERSITY OF NEBRASKA · Jul 21, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called Ramipril on patients with peripheral artery disease (PAD), specifically those who experience claudication, which is pain in the legs during walking due to poor blood flow. The study aims to find out if Ramipril can improve walking ability and overall quality of life by reducing muscle damage in the legs. Previous research has suggested that Ramipril may help patients walk better than some other common treatments for claudication.

To participate in this trial, individuals should be aged 65 to 87 and have a history of chronic claudication that limits their ability to walk. They should also have stable health conditions, such as controlled blood pressure and diabetes. However, those with more severe forms of PAD or other serious health issues are not eligible. Participants can expect to take the medication for a set period while being monitored for improvements in their walking performance and any side effects. Overall, this study could provide valuable insights into new treatment options for people living with claudication.

Gender

ALL

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.