OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

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.

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