DIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE

Completed

Conditions: Perifeer Arterieel vaatlijden (vaataandoeningen)
claudication

Registration Number: NL-OMON46719

Lead Sponsor: Radboud Universiteit Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 21

Inclusion Criteria

- stable intermittent claudication for at least three month;
- ABI (the ratio of BP in the lower legs to the BP in the arms) <0.9 and/or a ABI decreased by more than 0.15 after treadmill testing regardless of their ABI at rest;
- Rutherford classification for chronic limb ischemia 1-4 and/or Fontaine classification stage IIA-IIB or III.

Exclusion Criteria

- any condition other than PAD that limits walking;
- patients diagnosed with diagnosed with chronic kidney disease and/or or patients with insulin dependent diabetes;
- previous endovascular or surgical treatment for claudication within the last 12 months
- individuals with critical limb ischemia, who are wheel-chair bound, or who have an above or below-knee amputation;
- using dietary nitrate supplements;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter will be exercise tolerance, measured as peak walking time</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Exercise tolerance:<br /><br>* Claudication onset time (COT) and distance (COD)<br /><br>* VO2<br /><br><br /><br>Vascular function:<br /><br>* Flow mediated dilation (FMD)<br /><br>* Blood pressure (BP) and heart rate (HR)<br /><br>* Tissue oxygenation (NIRS)<br /><br><br /><br>Nitrate and nitrite:<br /><br>* Plasma nitrate and nitrite concentrations<br /><br>* Dietary intake</p><br>