Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
Population Health Research Institute
200 participants
Nov 2, 2020
INTERVENTIONAL
Conditions
Summary
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, cardiac structure and function, genomics, proteomics and metabolomics.
Eligibility
Inclusion Criteria9
- 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)
Exclusion Criteria7
- 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.
- Pregnancy
- Contraindication to bariatric surgery
- Prior bariatric surgery, other than gastric banding
- Life expectancy \<2 years from non-cardiovascular causes
- Inability to provide informed consent
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Interventions
Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.
The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
Locations(1)
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NCT05531474