Cardiovascular ComplicationBariatric Surgery Candidate
Investigational drug(s) / intervention(s)
Bariatric SurgeryMedical Weight Management
Bariatric 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.
Medical Weight Management: The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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)
Trial sites (1)
Facility
City
Region
Status
Hamilton Health Sciences
Hamilton
Ontario
Recruiting
More Population Health Research Institute trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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