NCT02842424 Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
| NCT ID | NCT02842424 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Nebraska |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2016-02-25 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2016-02-25 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Iraklis I Pipinos, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT02842424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02842424 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02842424 currently recruiting?
Yes, NCT02842424 is actively recruiting participants. Contact the research team at Holly.DeSpiegelaere@va.gov for enrollment information.
Where is the NCT02842424 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT02842424 clinical trial?
NCT02842424 is sponsored by University of Nebraska. The principal investigator is Iraklis I Pipinos, MD at University of Nebraska. The trial plans to enroll 70 participants.