Status:
TERMINATED
Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Conditions:
Metabolic Diseases
Endocrine System Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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. A...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00935766
Start Date
September 1 2009
End Date
March 1 2012
Last Update
September 29 2014
Active Locations (1)
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1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204