Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 4
- 主要终点
- The primary endpoint is change in coronary noncalcified plaque volume.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion criteria
- •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)
- •poor mental function or history of dementia/Alzheimer's Disease or on medications used for treatment of dementia [e.g. Tacrine (Cognex), Rivastigmine (Exelon), Galantamine (Razadyne, Reminyl), Donepezil (Aricept), Memantine (Namenda)] or any other reason to except patient difficulty in complying with the requirements of the study
- •medicine for erectile dysfunction within 72 hours prior to MDCTA
- •Prior stroke with residual cognitive deficit or functional deficit preventing any type of exercise
- •Current chemotherapy or radiation for malignancy
- •Current weekly alcohol consumption > 21 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
- •Exclusions based on nuclear imaging:
- •Transient cavity dilation
- •More than one vascular territory involved with reversible defect (multiple defects)
- •Reversible defects involving the anterior wall, septum or apex (LAD territory)
- •Exclusions based on echocardiography imaging:
- •More than one vascular territory involved with inducible wall motion abnormalities (multiple defects)
- •Inducible wall motion abnormalities involving the anterior wall, septum or apex (LAD territory)
排除标准
- 未提供
研究组 & 干预措施
Usual care
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)
干预措施: Omega 3 acid ethyl esters (Dietary Supplement)
结局指标
主要结局
The primary endpoint is change in coronary noncalcified plaque volume.
时间窗: Baseline and 30 months
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.
次要结局
- Effect of Lovaza on Physical Function, Pain, Stiffness and Exercise(Baseline and 1 year)
- Nonalcoholic steatohepatitis (NASH)(Baseline and 30 months)
- Coronary artery plaque assessment(Baseline and 30 months)
- Inflammatory markers(Baseline and 30 months)
- Pericardial Fat(Baseline and 30 months)
- Insulin Resistance(Baseline and 30 months)
- Vitamin D Levels and coronary plaque progression(Baseline and 30 months)
- Exercise capacity and coronary plaque(Baseline)
- Urinary microalbumin and coronary plaque(Baseline and 30-months)
- Cognitive function(Baseline, 1 year and 30-months)
研究者
Francine K. Welty
Associate Professor of Medicine
Beth Israel Deaconess Medical Center