Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
Condition: Metabolic Diseases; Endocrine System Diseases; Heart Disease; Vascular Diseases; Diabetes; Cardiovascular Disease; Glucose Metabolism Disorders; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Intervention: Omega-3; Placebo
Intervention description: Subjects meeting eligibility criteria will be randomized to receive a supply of omega-3-acid ethyl esters or placebo, and instructed to take 4 capsules daily. A 3-month supply of study drug will be given following randomization and at 3, 6, and 9 months. Subjects will be asked to bring unused supplies to each quarterly visit for ascertainment of adherence.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Latinos Using Cardio Health Actions to Reduce Risk; Omega three Fatty Acids; Vascular Function and Inflammation

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.
    

Eligibility 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