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Metabolic DiseasesPhase 3NCT00935766

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

A Phase 3 study testing Omega-3 in people with Metabolic Diseases and Endocrine System Diseases, run by Denver Health and Hospital Authority at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Omega-3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteUnited States
Study dates
Sep 2009to Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of HTN
  • Hispanic or Non-Hispanic White
  • Age > 18
  • One additional CVD risk factor
  • Age > 55 for males or >65 for females
  • DM
Show all 33Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

Other trials in United States

About this study

Official title: Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Effect of Omega-3 Fatty Acids on Vascular Function and Inflammation

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.

Read more

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.
Read the 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.

Being tested
Omega-3, Placebo
Keywords
Latinos Using Cardio Health Actions to Reduce Risk, Omega three Fatty Acids, Vascular Function and Inflammation
Medical subject headings
Metabolic Diseases, Endocrine System Diseases, Heart Diseases, Vascular Diseases, Diabetes Mellitus, Cardiovascular Diseases, Glucose Metabolism Disorders, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3Drug

    Also called Lovaza

    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.

  • PlaceboDrug

    Also called Sugar pill

Study groups in NCT00935766
Study groupRoleWhat they receive
Sugar PillPlacebo comparator4 tabs of placebo dependent on randomization
Receives: Drug: Placebo
Omega 3Active comparatoromega-3-acid ethyl esters and instructed to take 4 1 mg capsules daily
Receives: Drug: Omega-3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    .

    Measured: Baseline, 3 months

Secondary outcomes (2)

  1. Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)

    Measured: baseline, 3 months

  2. Change in hsCRP

    Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: The study was discontinued early due to lack of funding and slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00935766
Sponsor's protocol ID
08-0722 LUCHAR AIM 4
Status last verified
Sep 2014
First submitted
8 Jul 2009
Last updated
29 Sep 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 26631058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3 in people with Metabolic Diseases and Endocrine System Diseases, run by Denver Health and Hospital Authority at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients. (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00935766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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