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

Medical University of Vienna71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change from baseline endothelial function to 3 months

measured by flow mediated vasodilation

Time frame: baseline, 3 months

Secondary Outcomes

change from baseline endothelial function to six months

Time frame: baseline, 6 months (3 months after treatment cessation)

change of walking distance (maximum/pain-free)from baseline to three months and six months

Time frame: baseline, 3, 6 months

change of inflammatory markers from baseline to one, three and six months

Time frame: baseline, 1, 3, 6 months

change of pulse wave velocity from baseline to one, three and six months

Time frame: baseline, 1, 3, 6 months

bleeding events

Time frame: 1, 3, 6 months

liver enzymes changes

Time frame: baseline, 1,3,6 months

change of platelet activation from baseline to one, three and six months

Time frame: baseline, 1, 3, 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes