Nitrites, Exercise, and Peripheral Arterial Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | November 2014 |
Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD
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).
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).
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
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