Actively Recruiting
Bariatric Surgery for the Reduction of Cardiovascular Events Randomized Controlled Trial
Led by Population Health Research Institute · Updated on 2026-05-28
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of bariatric surgery compared to medical weight management (MWM) in patients with severe obesity and high-risk cardiovascular disease (CVD). The study aims to determine if bariatric surgery can safely reduce the risk of major cardiovascular events. It also examines the cost-effectiveness of bariatric surgery and includes additional sub-studies on mental health, cognition, cardiac structure and function, and molecular profiling. Participants will be randomly assigned to receive either bariatric surgery or medical weight management. Bariatric surgery options include gastric bypass, sleeve gastrectomy, or duodenal switch, chosen by the surgeon. Medical weight management involves standard care such as dietary, lifestyle, and behavioral counseling, which may include low-calorie diets, meal replacements, or anti-obesity medications based on local practices. Surgery patients may receive a low-fat, high-protein meal replacement before the procedure, and perioperative care follows local guidelines. During the study, participants will be monitored for cardiovascular outcomes over an average of 6 years, with additional mental health and cognition assessments at 3 years. The study tracks events like heart attacks, strokes, hospitalizations, diabetes status, and heart rhythm changes. Researchers will also analyze cost-effectiveness in quality adjusted life years. Safety and health status will be regularly assessed, and participant involvement includes ongoing follow-up visits and evaluations throughout the study period.
CONDITIONS
Brief Title
Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 30 kg/m2 or higher; OR BMI 30 to 34.9 kg/m2 with type 2 diabetes or age over 55 years
- Age 18 years or older
- High-risk cardiovascular disease, defined by any of the following:
- History of major coronary artery disease events or significant artery blockages
- Left ventricular ejection fraction less than 40%
- Heart failure with preserved ejection fraction and recent hospitalization or elevated natriuretic peptides
- Documented atrial fibrillation with stroke risk score of 2 or higher
- History of any stroke
- Documented peripheral arterial disease with specific criteria
You will not qualify if you...
- Hospital admission for heart failure, myocardial infarction, stroke, or coronary revascularization within 30 days before randomization
- Percutaneous coronary intervention with a drug eluting stent within 90 days before randomization
- Pregnancy
- Contraindication to bariatric surgery
- Prior bariatric surgery other than gastric banding
- Life expectancy under 2 years from non-cardiovascular causes
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years
Participants receive either bariatric surgery or medical weight management according to local practice standards.
Visits occur as needed for surgery and regular medical weight management follow-up
Duration - Up to 6 years
Participants are monitored for cardiovascular outcomes and other health measures after treatment.
Long-term follow-up visits over approximately 6 years
Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
Research Team
J
Jorge Wong, MD, MPH, FRCPC
S
Sumathy Rangarajan, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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