OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
71 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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