N/A
Completed N=21
Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
Source: ClinicalTrials.gov NCT01983826 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Change in Vasodilator Capacity — 16.2; 16.4; 16.5; 14.2 ml/100ml tissue/min
Summary
The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vasodilator Capacity |
16.2; 16.4; 16.5; 14.2; 11.6; 14.1 | — |
| PRIMARY Change in Arterial Stiffness |
13.8; 12.8; 10.5; 11.0 | — |
| PRIMARY Change in Functional Capacity - Distance Walked in 6 Minutes |
387; 425; 423; 427 | — |
Eligibility Criteria
Inclusion Criteria
- Documented peripheral artery disease
- Ankle-Brachial Index (ABI) 180 mmHg or diastolic pressure > 100 mmHg
- Hypotension (resting systolic BP < 90 mmHg)
- Smoking or history of smoking within past one year
- Use of phosphodiesterase V inhibitor drugs
- Women with history of hormone replacement therapy within the past 6 months
Data sourced from ClinicalTrials.gov (NCT01983826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.