Nitrites, Exercise, and Peripheral Arterial Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

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).

Key facts

Study ID

NCT01684930

Run by

Duke University

People needed

32

Starts

2012-06-01

Expected to finish

2014-11-01

Last updated by the study team

2017-08-29

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Peripheral Arterial Disease (ABI of less than 0.9)
• Intermittent Claudication for 3 or more months

You may not qualify if…

• 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

Where it is running

• Duke Diet & Fitness Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.