IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization.

Locations
United States
Arizona
University of Arizona
NOT_YET_RECRUITING
Tucson
California
Rancho Research Institute
RECRUITING
Downey
Georgia
Emory University School of Medicine
NOT_YET_RECRUITING
Atlanta
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
New Hampshire
Dartmouth Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
Pennsylvania
University of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Mary M McDermott, MD
mdm608@northwestern.edu
312-503-6438
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2032-08-01
Participants
Target number of participants: 386
Treatments
Experimental: Home based exercise + nitrate rich beetroot juice
This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months.
Placebo_comparator: Home-based exercise + placebo
This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months.
Experimental: Attention control + nitrate-rich beetroot juice
This group will be participating in attention control and drinking nitrate rich beetroot juice for six months.
Placebo_comparator: Attention control + placebo
This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.
Sponsors
Collaborators: Emory University, University of Arizona, Rancho Research Institute, Dartmouth-Hitchcock Medical Center, Wake Forest University, University of Pittsburgh Medical Center, University of Chicago
Leads: Northwestern University

This content was sourced from clinicaltrials.gov