Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of LUCHAR Specific Aims 4.1 and 4.2 is to assess the additional contribution of cardiovascular disease (CVD) risk markers to traditional biomedical risk factors in the prediction of pre-clinical CVD. Specific Aim 4.3 will test the impact of omega-3 fatty acid supplementation on risk markers and pre-clinical markers of CVD in Hispanic patients.

Specific Aim 4.3: Conduct a randomized, placebo-controlled trial of the effect of omega-3 fatty acid supplementation on vascular function as measured by brachial artery reactivity (BAR) and on circulating inflammatory markers.

Hypotheses:

1. Daily omega-3 fatty acid supplementation will improve vascular function in subjects at high risk for CVD.

2. Daily omega-3 fatty acid supplementation will reduce inflammatory protein panel scores in subjects at high risk for CVD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Collaborators: GlaxoSmithKline; National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Diagnosis of HTN

• Hispanic or Non-Hispanic White

• Age > 18

• One additional CVD risk factor

• Age > 55 for males or >65 for females

• DM

• Dyslipidemia O TC >220 or O LDL >130 or O on statin therapy

• Current smoker

• Chronic kidney disease defined as GFR <60 ml/min/1.72m2

• BMI > 30 kg/m2

• Positive microalbuminuria -Able to sign consent form and willing to complete 12-month follow- up period.

Exclusion criteria used for SA3/4 will also apply for Aim 4.3. These include factors rendering assessment of endothelial function unreliable, such as:

• Clinically manifest CVD (including angina, myocardial infarction, surgical or percutaneous coronary revascularization, stroke, cerebrovascular revascularization, peripheral vascular disease, heart failure, or valvular heart disease

• Electrocardiographic evidence of prior myocardial infarction

• Known valvular heart disease of at least moderate severity

• Known left ventricular systolic dysfunction (LVEF < 0.50)

• End-stage renal disease

• History of inflammatory disease or vasculitis (including rheumatoid arthritis, systemic lupus erythematosis, Raynaud phenomenon, or other connective tissue disease/vasculitides)

• Corticosteroid therapy

• Active substance abuse

• Projected life-expectancy <12 months due to comorbid condition

• Plans to move away from the Denver area within 12 months

• Previous trauma or surgery of the brachial artery

• Upper arm circumference exceeding 42 cm.

Additional exclusion criteria for participation in Aim 4.3 include:

• Pregnancy or breast-feeding

• Known sensitivity or allergy to fish

• Known sensitivity or allergy to omega-3 fatty acid supplements

• Taking omega-3 fatty acid supplements in the last 2 weeks- may participate after 2 week washout

• Triglycerides > 500 mg/dL.

• Alanine aminotransferase (ALT) levels above 3x upper limit of normal

• Not a good candidate for participation based on the opinion of the investigators.

• Current therapy with a fibric acid derivative