Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids

NCT01624727 | Completed DMC

• 2 other identifiers: 2006P000175P50HL083813
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Heart Disease; Metabolic Syndrome

Keywords

Coronary heart disease; metabolic syndrome; CT angiography

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is change in coronary noncalcified plaque volume.

  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. The hypothesis is that those on Lovaza will have less progression of coronary plaque compared to those in usual care.

  Baseline and 30 months

Secondary Outcomes (10)

• Coronary artery plaque assessment

  Baseline and 30 months

• Effect of Lovaza on Physical Function, Pain, Stiffness and Exercise

  Baseline and 1 year

• Inflammatory markers

  Baseline and 30 months

• Pericardial Fat

  Baseline and 30 months

• Insulin Resistance

  Baseline and 30 months

Study Arms (2)

Usual care

NO INTERVENTION

Those randomized to usual care will continue to follow the care provided by their cardiologist. They will have all the follow-up phone calls, visits and testing which the intervention group has.

Lovaza (Omega 3 ethyl esters)

ACTIVE COMPARATOR

Dietary Supplement: Omega 3 acid ethyl esters

Interventions

Omega 3 acid ethyl esters DIETARY_SUPPLEMENT

Lovaza 3.6 g daily

Lovaza (Omega 3 ethyl esters)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• coronary artery disease
• previous myocardial infarction
• angioplasty (\> 6 months ago)
• previous coronary bypass surgery (\> 12 months ago)
• stable angina
• non-calcified plaque on prior CT
• abnormal exercise tolerance test
• aged 21- 80 years
• BMI ≥ 27 kg/m2 and ≤ 35 kg/m2 if female and ≤ 40 kg/m2 if male (a BMI \> 24.5 for subjects from Asian origin)
• stable dose of statin for 1 month at screening or unable to tolerate a statin
• normal renal function - estimated creatinine clearance calculated using Cockcroft-Gault (CG) equation ≥60 at screening \[eCrCLCG (ml/min) = \[(140 - age) x weight (kg)\]/\[SCr(mg/dl) x 72\] x \[0.85 if female\] or serum Cr \< 1.3
• ALT, AST) \< 3 times upper limits of normal)
• normal thyroid function or on stable dose replacement therapy
• an ETT performed within 12 months prior

You may not qualify if:

• unstable angina (increase in frequency or severity of anginal episodes or development of chest pain at rest)
• significant obstructive disease in left main coronary artery, ostial LAD or newly diagnosed three-vessel disease since prior cardiac catheterization by MDCTA
• significant heart failure (NYHA class III and IV)
• Current atrial fibrillation or Wolf-Parkinson-White (WPW) syndrome
• allergy to beta-blocker in subjects with resting heart rate \> 65 bpm
• systolic blood pressure \> 160 mm Hg
• diastolic BP \> 100 mm Hg
• persons with allergies to iodinated contrast material or shellfish
• allergy to nitroglycerin
• history of asthma only if unable to tolerate beta-blockers
• BMI \> 35 kg/m2 if female and \> 40 kg/m2 if male
• body weight \> 350 lbs
• Use of drugs for weight loss \[eg Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanolamine) or similar over-the-counter medications\] within three months of screening
• surgery within 30 days of screening
• history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Tufts Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

South Shore Medical Group

Milton, Massachusetts, 02186, United States

Location

Related Publications (8)

• Welty FK, Hariri E, Asbeutah AA, Daher R, Amangurbanova M, Chedid G, Elajami TK, Alfaddagh A, Malik A. Regression of Coronary Fatty Plaque and Risk of Cardiac Events According to Blood Pressure Status: Data From a Randomized Trial of Eicosapentaenoic Acid and Docosahexaenoic Acid in Patients With Coronary Artery Disease. J Am Heart Assoc. 2023 Sep 19;12(18):e030071. doi: 10.1161/JAHA.123.030071. Epub 2023 Sep 8.

  PMID: 37681568 DERIVED

• Chedid G, Malik A, Daher R, Welty FK. Higher exercise capacity, but not omega-3 fatty acid consumption, predicts lower coronary artery calcium scores in women and men with coronary artery disease. Atherosclerosis. 2023 Nov;384:117168. doi: 10.1016/j.atherosclerosis.2023.06.074. Epub 2023 Jun 26.

  PMID: 37541921 DERIVED

• Welty FK, Schulte F, Alfaddagh A, Elajami TK, Bistrian BR, Hardt M. Regression of human coronary artery plaque is associated with a high ratio of (18-hydroxy-eicosapentaenoic acid + resolvin E1) to leukotriene B4. FASEB J. 2021 Apr;35(4):e21448. doi: 10.1096/fj.202002471R.

  PMID: 33749913 DERIVED

• Malik A, Ramadan A, Vemuri B, Siddiq W, Amangurbanova M, Ali A, Welty FK. omega-3 Ethyl ester results in better cognitive function at 12 and 30 months than control in cognitively healthy subjects with coronary artery disease: a secondary analysis of a randomized clinical trial. Am J Clin Nutr. 2021 May 8;113(5):1168-1176. doi: 10.1093/ajcn/nqaa420.

  PMID: 33675344 DERIVED

• Malik A, Kanduri JS, Asbeutah AAA, Khraishah H, Shen C, Welty FK. Exercise Capacity, Coronary Artery Fatty Plaque, Coronary Calcium Score, and Cardiovascular Events in Subjects With Stable Coronary Artery Disease. J Am Heart Assoc. 2020 Apr 7;9(7):e014919. doi: 10.1161/JAHA.119.014919. Epub 2020 Mar 26.

  PMID: 32212910 DERIVED

• Alfaddagh A, Elajami TK, Saleh M, Mohebali D, Bistrian BR, Welty FK. An omega-3 fatty acid plasma index >/=4% prevents progression of coronary artery plaque in patients with coronary artery disease on statin treatment. Atherosclerosis. 2019 Jun;285:153-162. doi: 10.1016/j.atherosclerosis.2019.04.213. Epub 2019 Apr 13.

  PMID: 31055222 DERIVED

• Alfaddagh A, Elajami TK, Ashfaque H, Saleh M, Bistrian BR, Welty FK. Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial. J Am Heart Assoc. 2017 Dec 15;6(12):e006981. doi: 10.1161/JAHA.117.006981.

  PMID: 29246960 DERIVED

• Elajami TK, Alfaddagh A, Lakshminarayan D, Soliman M, Chandnani M, Welty FK. Eicosapentaenoic and Docosahexaenoic Acids Attenuate Progression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease. J Am Heart Assoc. 2017 Jul 14;6(7):e004740. doi: 10.1161/JAHA.116.004740.

  PMID: 28710178 DERIVED

MeSH Terms

Conditions

Coronary Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Francine K Welty, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: June 21, 2012
• Study Start: June 1, 2009
• Primary Completion: January 15, 2015
• Study Completion: January 15, 2015
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

US (2)