The Effects of Inorganic Nitrite on skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients suffering from Intermittent Claudication.

Phase 1

• Conditions: Peripheral arterial Disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000201-72-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

Patients with stable intermittent claudication 1) of at least 3 months duration 2) with clinical findings of peripheral vascular disease and 3) an ABPI<0.9.
Strict attention will be paid to secondary prevention measures and patients will be advised to exercise regularly. Patients will not be offered supervised exercise therapy. Dietary nitrite/nitrate intake will be assessed via a short questionnaire. Patients with a high dietary intake will not be excluded from the study as we wish to assess the effects or oral sodium nitrate supplementation on platelet function irrespective if a patient’s diet.
They should be able to walk for at least one minute on a treadmill using the Skinner-Gardner protocol and the variability in absolute claudication distance (ACD) between two consecutive baseline tests performed within a two week period should be less than 25%.
Patients must be on a statin and aspirin for at least six weeks prior to being enrolled in this study. Patients on pentoxyifylline, cilostazol, or dietary supplements such as omega-3 fatty acids and l-arginine will require a 1 month washout period prior to enrolment.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

Patients with the following will be excluded:
•rest pain or ulceration
•recent arterial revascularisation (within the past 3 months)
•other co-morbidities that may impede the patient’s ability to perform an exercise test (arthritis, severe coronary artery disease or chronic obstructive pulmonary disease)
•Patients on clopidogrel
•oral nitrate preparations

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified