Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Cardiovascular Outcomes
研究概览
简要总结
The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are >55 years of age
- •Age ≥18 years
- •High-risk CVD, defined as the presence of any one of the following:
- •High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
- •Left ventricular ejection fraction (LVEF) < 40%
- •Heart failure with preserved ejection fraction (LVEF > 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) > 300 pg/ml or BNP > 100 pg/ml in the past 12 months
- •Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
- •History of any stroke
- •Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)
排除标准
- •Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
- •Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
- •Contraindication to bariatric surgery
- •Prior bariatric surgery, other than gastric banding
- •Life expectancy <2 years from non-cardiovascular causes
- •Inability to provide informed consent
研究组 & 干预措施
Medical Weight Management
MWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and/or behavioral modification counseling, which may include nutritional counseling, safe weight management and/or making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and/or anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines.
干预措施: Medical Weight Management (Behavioral)
Bariatric Surgery
The bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. .
干预措施: Bariatric Surgery (Procedure)
结局指标
主要结局
Cardiovascular Outcomes
时间窗: Through study completion, expected average of 6 years
Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).
次要结局
- Hospitalization for heart failure(Through study completion, expected average of 6 years)
- All-cause mortality(Through study completion, expected average of 6 years)
- Myocardial infarction(Through study completion, expected average of 6 years)
- Cost effectiveness analysis, measured in quality adjusted life years(Through study completion, expected average of 6 years)
- Cardiovascular mortality(Through study completion, expected average of 6 years)
- Stroke(Through study completion, expected average of 6 years)
- New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring(Through study completion, expected average of 6 years)
- New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines(Through study completion, expected average of 6 years)