NCT01624727

Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids

Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.

Detailed description

Study Design: This is a randomized, parallel study design with a usual care control group. 278 subjects with coronary heart disease (CHD) are being randomized to omega-3 supplementation or standard of care (139 in each arm). Multidetector computed tomographic angiography (MDCTA) is performed at baseline to quantitate the amount of noncalcified and calcified coronary plaque and again at 30 month follow-up to determine if there has been a change in the volume of noncalcified or total plaque. The primary endpoint is change in coronary noncalcified plaque volume during the 30 months of intervention between active and standard of care. Hypothesis: Percent change in progression of coronary plaque volume will be less for the omega-3 fatty acid intervention compared to standard of care. Secondary endpoints include plasma levels of inflammatory markers, lipids and measures of insulin sensitivity. Secondary outcomes include testing the hypothesis that targeting inflammation with omega-3 fatty acids will be associated with: 1. Change in total plaque volume per patient. 2. improvement in physical function and exercise and reduction in pain and stiffness as measured by the WOMAC questionnaire 3. Reduction of mediators of inflammation in the circulation including CRP, PAI-1, serum amyloid A, MMP-9 and fibrinogen, pro-inflammatory cytokines including IL-6, TNF-a and IL-1b, the adhesion molecules VCAM-1 and ICAM-1, increase in adiponectin and reduction in serum nitrotyrosine as a marker of oxidative stress. 4. Reduction of insulin resistance assessed by fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR). 5. Reduction of inflammation in the liver associated with nonalcoholic steatohepatitis (NASH), a newly recognized component of the metabolic syndrome, and reduction of fatty liver quantitated by computerized tomography and levels of AST and ALT as markers of liver inflammation related to NASH. 6. Investigation of the relationship between vitamin D status and coronary plaque progression as well as with insulin resistance (HOMA-IR), beta-cell function (HOMA-%beta) and inflammatory cytokines. 7. Determination of whether baseline vitamin D levels predict clinical response to the omega-3 fatty acid intervention, and whether hypovitaminosis D is associated with plaque progression.

Conditions

• Coronary Heart Disease
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega 3 acid ethyl esters	Lovaza 3.6 g daily

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-01-15
• Completion: 2015-01-15
• First posted: 2012-06-21
• Last updated: 2017-09-27

Locations

2 sites across 1 country: United States