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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00935766
Recruitment Status : Terminated (The study was discontinued early due to lack of funding and slow enrollment)
First Posted : July 9, 2009
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Carlin Long, Denver Health and Hospital Authority

Brief 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.


  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.

Condition or disease Intervention/treatment Phase
Metabolic Diseases Endocrine System Diseases Heart Disease Vascular Diseases Diabetes Cardiovascular Disease Glucose Metabolism Disorders Hypertension Drug: Omega-3 Drug: Placebo Phase 3

Detailed Description:

Omega-3 fatty acids reduce triglycerides (TG) in a manner similar to fibric acids by lowering hepatic TG release, reducing VLDL production, stimulating lipoprotein lipase and enhancing TG clearance. Although statins are widely utilized among DH patients, our overall population, even those with CHD, have fairly low levels of LDL-cholesterol (Krantz et al, 2004). This likely reflects our population that is predominantly Latino with a high incidence of metabolic syndrome. Among our patients, we often achieve LDL-c NCEP targets, yet secondary goals for non-HDL, HDL, and TG are rarely achieved. This is an unmet opportunity given the strong independent contribution of non-HDL (McQueen et al, 2008), HDL (D'Agostino et al, 2008) and TG (Nordestgaard et al, 2007, Tirosh et al, 2007) to CHD risk, which may be particularly important in Latino populations.

The study drug (LOVAZA) improves the TC/HDL ratio which is the strongest predictor of CHD events based on the ~30,000 patient Interheart study noted above. LOVAZA has no hepatic P450 effects and for that matter no meaningful clinical adverse effects, making it advantageous for use in a population with multiple co-morbidities who are at risk for drug-drug interactions and have difficulty with medication adherence. Given the high incidence of insulin resistance among DH's predominately Latino CHD population, and strong lipid (Harris et al, 1997; Davidson et al 2007) as well outcome data in CHD (GISSI investigators, 1999) this agent has potential clinical utility in our population.

To date, improved outcomes in non-CHD populations have not been demonstrated prospectively with LOVAZA. Although recent data suggest promising effects on inflammatory makers such as LpPLA2, the impact of LOVAZA on pre-clinical markers of atherosclerosis such as BAR and CIMT have not been well characterized particularly among Latinos. Moreover, changes in inflammatory markers have been limited and more expansive evaluations are currently available. Against this background we assessed whether LOVAZA might improve atherosclerotic risk via improvement in flow mediated dilation of the brachial artery as well as through reduction in a comprehensive inflammatory marker panel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Effect of Omega-3 Fatty Acids on Vascular Function and Inflammation
Study Start Date : September 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Sugar Pill
4 tabs of placebo dependent on randomization
Drug: Placebo
Other Name: Sugar pill

Active Comparator: Omega 3
omega-3-acid ethyl esters and instructed to take 4 1 mg capsules daily
Drug: Omega-3
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.
Other Name: Lovaza

Primary Outcome Measures :
  1. Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients. [ Time Frame: Baseline, 3 months ]

    We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega-3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV.


Secondary Outcome Measures :
  1. Change in Lipoprotein-associated Phospholipase A2 (LpPLA2) [ Time Frame: baseline, 3 months ]
  2. Change in hsCRP [ Time Frame: baseline, 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00935766

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United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Carlin S Long, MD Denver Health Medical Center Chief of Cardiology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carlin Long, Cardiologist, Denver Health and Hospital Authority Identifier: NCT00935766    
Other Study ID Numbers: 08-0722 LUCHAR AIM 4
First Posted: July 9, 2009    Key Record Dates
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2014
Last Verified: September 2014
Keywords provided by Carlin Long, Denver Health and Hospital Authority:
Latinos Using Cardio Health Actions to Reduce Risk
Omega three Fatty Acids
Vascular Function and Inflammation
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases