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

NCT00935766 | Terminated Phase 3 Results

• 1 other identifier: 08-0722 LUCHAR AIM 4
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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:

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

Conditions

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

Outcome Measures

Primary Outcomes (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. .

  Baseline, 3 months

Secondary Outcomes (2)

• Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)

  baseline, 3 months

• Change in hsCRP

  baseline, 3 months

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

4 tabs of placebo dependent on randomization

Drug: Placebo

Omega 3

ACTIVE COMPARATOR

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

Drug: Omega-3

Interventions

Omega-3 DRUG

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.

Also known as: Lovaza

Omega 3

Placebo DRUG

Also known as: Sugar pill

Sugar Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HTN
• Hispanic or Non-Hispanic White
• Age \> 18
• One additional CVD risk factor
• Age \> 55 for males or \>65 for females
• 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.

You may not qualify if:

• 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.
• Pregnancy or breast-feeding
• Known sensitivity or allergy to fish
• Known sensitivity or allergy to omega-3 fatty acid supplements

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 26631058 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Vascular Diseases; Diabetes Mellitus; Cardiovascular Diseases; Glucose Metabolism Disorders; Hypertension; Inflammation

Interventions

Docosahexaenoic Acids; Omacor; Sugars

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Carbohydrates

Limitations and Caveats

The study was discontinued early due to lack of funding and slow enrollment

Results Point of Contact

• Title: Carlin Long, MD
• Organization: Denver Health Medical Center

carlin.long@dhha.org

303-602-3899

Study Officials

• Carlin S Long, MD

  Denver Health Medical Center Chief of Cardiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 29, 2014
• Results First Posted: September 29, 2014

Record last verified: 2014-09

Locations

US (1)