Peripheral Arterial Disease Clinical Trial
Official title:
OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL
The principal aim of the study is to determine the effects n3-PUFA on top of standard
therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.
Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.
Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation
using brachial artery ultrasound.
Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse
wave velocity, whole blood viscosity, platelet activation and plasma markers of
inflammation.
Status | Completed |
Enrollment | 71 |
Est. completion date | March 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Severity of disease: Rutherford category II or III - moderate to severe Stable intermittent claudication - Ankle Brachial Index<0.9 - Age =18 years - Adequate PAD therapy according to current AHA guidelines Exclusion Criteria: - Current treatment with Omacor or other fish oil products - Planned vascular intervention - Known hypersensitivity to the study drug - Rest pain or ischemic ulcer - Exercise tolerance limited by factors other than PAD - Inability to perform treadmill test - Dual antiplatelet therapy (aspirin and clopidogrel) - Previous myocardial infarction - Known liver diseases, except fatty liver - Known bleeding diathesis - Women of childbearing potential who do not practice a safe contraception method - Current participation in another intervention study. - Previous participation in another study with an intervention within the last 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna, Department of Internal Medicine II, Division of Angiology | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline endothelial function to 3 months | measured by flow mediated vasodilation | baseline, 3 months | No |
Secondary | change from baseline endothelial function to six months | baseline, 6 months (3 months after treatment cessation) | No | |
Secondary | change of walking distance (maximum/pain-free)from baseline to three months and six months | baseline, 3, 6 months | No | |
Secondary | change of inflammatory markers from baseline to one, three and six months | baseline, 1, 3, 6 months | No | |
Secondary | change of pulse wave velocity from baseline to one, three and six months | baseline, 1, 3, 6 months | No | |
Secondary | bleeding events | 1, 3, 6 months | Yes | |
Secondary | liver enzymes changes | baseline, 1,3,6 months | Yes | |
Secondary | change of platelet activation from baseline to one, three and six months | baseline, 1, 3, 6 months | No |
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