Bariatric Surgery Candidate, Cardiovascular Complication
Conditions
Brief 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 and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.
Interventions
PROCEDUREBariatric Surgery
Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.
BEHAVIORALMedical Weight Management
The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Age ≥18 years 3. High-risk CVD, defined as the presence of any one of the following: 1. 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) 2. Left ventricular ejection fraction (LVEF) \< 40% 3. 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 4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score 5. History of any stroke 6. 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 criteria
1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization 2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization. 3. Pregnancy 4. Contraindication to bariatric surgery 5. Prior bariatric surgery, other than gastric banding 6. Life expectancy \<2 years from non-cardiovascular causes 7. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Outcomes | Through study completion, expected average of 6 years | Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF). |
| BRAVE-Mind Sub-study Measures | 3 years | 1. Depressive symptoms asessed with the Patient Health Questionnaire-8 (PHQ-8) 2. Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA) Secondary Outcome Measures: 3. Executive function and processing speed assessed with the Number Symbol Coding Task (NSCT) 4. Functional capacity assessed with the Standardized Assessment of Global Activities in the Elderly (SAGE) 5. Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 (GAD-7) 6. Nonnormative eating symptoms assessed with the Loss of Control Over Eating-Brief (LOCES-B) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Through study completion, expected average of 6 years | — |
| Cardiovascular mortality | Through study completion, expected average of 6 years | — |
| Myocardial infarction | Through study completion, expected average of 6 years | — |
| Stroke | Through study completion, expected average of 6 years | — |
| Hospitalization for heart failure | 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 | — |
| New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring | 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 | Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management |
Countries
Canada
Contacts
CONTACTJorge Wong, MD, MPH, FRCPC
CONTACTSumathy Rangarajan, MSc
PRINCIPAL_INVESTIGATORSalim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC
Population Health Research Institute
Outcome results
None listed