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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 23, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Secondary endpoints: details revised at 2 of 23 entriesv7
  3. Trial status: Suspended to Recruiting Primary and study completion dates: Jun 2024 to Jun 2026 · Secondary endpoints revised (23) · Site details revisedv6 Show 3 more changesShow less
    • Primary and study completion dates: Jun 2024 to Jun 2026
    • Secondary endpoints revised (23)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Suspended Sponsor's reason: IRB administratively closed protocol Start date: Oct 2015 to Feb 25, 2016 · Completion date: Jun 30, 2024 to Jun 2024 · Site details revised · 1 morev5 Show 4 more changesShow less
    • Start date: Oct 2015 to Feb 25, 2016
    • Completion date: Jun 30, 2024 to Jun 2024
    • Site details revised
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Mar 2020 to Jun 2024 Completion date: Mar 31, 2020 to Jun 30, 2024v4 Show 1 more changeShow less
    • Completion date: Mar 31, 2020 to Jun 30, 2024
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Completion date: Mar 31, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02842424
Lead Sponsor University of Nebraska
Conditions Peripheral Arterial Disease
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov