Nitrites, Exercise, and Peripheral Arterial Disease

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Peripheral Arterial Disease (ABI of less than 0.9)

• Intermittent Claudication for 3 or more months

Exclusion Criteria:

• Individuals with known alcohol or drug abuse problems

• Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months

• Those classified as American Heart Association Class D

• Gangrene, impending limb loss or osteomyelitis

• Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment

• Severe peripheral neuropathy

• Any condition other than PAD that limits walking

• Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise

• Subjects taking nitrates or nitroglycerin products

• Must not be taking protein pump inhibitor medications