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

Primary Purpose

Metabolic Diseases, Endocrine System Diseases, Heart Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Diseases focused on measuring Latinos Using Cardio Health Actions to Reduce Risk, Omega three Fatty Acids, Vascular Function and Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver Health and Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar Pill

Omega 3

Arm Description

4 tabs of placebo dependent on randomization

omega-3-acid ethyl esters and instructed to take 4 1 mg capsules daily

Outcomes

Primary Outcome Measures

Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.
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

Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)
Change in hsCRP

Full Information

First Posted
July 8, 2009
Last Updated
September 23, 2014
Sponsor
Denver Health and Hospital Authority
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00935766
Brief Title
Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
Official Title
Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Effect of Omega-3 Fatty Acids on Vascular Function and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued early due to lack of funding and slow enrollment
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. Hypotheses: Daily omega-3 fatty acid supplementation will improve vascular function in subjects at high risk for CVD. Daily omega-3 fatty acid supplementation will reduce inflammatory protein panel scores in subjects at high risk for CVD.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases, Endocrine System Diseases, Heart Disease, Vascular Diseases, Diabetes, Cardiovascular Disease, Glucose Metabolism Disorders, Hypertension
Keywords
Latinos Using Cardio Health Actions to Reduce Risk, Omega three Fatty Acids, Vascular Function and Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
4 tabs of placebo dependent on randomization
Arm Title
Omega 3
Arm Type
Active Comparator
Arm Description
omega-3-acid ethyl esters and instructed to take 4 1 mg capsules daily
Intervention Type
Drug
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Lovaza
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.
Description
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. .
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)
Time Frame
baseline, 3 months
Title
Change in hsCRP
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlin S Long, MD
Organizational Affiliation
Denver Health Medical Center Chief of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26631058
Citation
Krantz MJ, Havranek EP, Pereira RI, Beaty B, Mehler PS, Long CS. Effects of omega-3 fatty acids on arterial stiffness in patients with hypertension: a randomized pilot study. J Negat Results Biomed. 2015 Dec 2;14:21. doi: 10.1186/s12952-015-0040-x.
Results Reference
derived

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

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