RECRUITING

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Quick Facts

Study Start:2016-02-25
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02842424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A positive history of chronic claudication,
  2. 2. Exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon,
  3. 3. Arterial occlusive disease per ankle Brachial index measurements and/or other imaging modalities,
  4. 4. Stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.
  1. 1. Rest pain or tissue loss due to PAD (Fontaine stage III and IV),
  2. 2. acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
  3. 3. Walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology,
  4. 4. Current use of either ACE inhibitors or angiotensin II receptor blockers,
  5. 5. Chronic kidney disease with estimated Glomerular Filtration Rate \< 30 ml/min/1.73 m2,
  6. 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.

Contacts and Locations

Study Contact

Holly DeSpiegelaere
CONTACT
402-995-4171
Holly.DeSpiegelaere@va.gov

Principal Investigator

Iraklis I Pipinos, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska
George P Casale, PhD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

VA Medical Center
Omaha, Nebraska, 68105
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Iraklis I Pipinos, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska
  • George P Casale, PhD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-02-25
Study Completion Date2026-06

Study Record Updates

Study Start Date2016-02-25
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Ramipril
  • Angiotensin-converting enzyme
  • Claudication
  • Myopathy
  • Peripheral Arterial Disease

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease