NCT05531474

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Complication
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	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.
BEHAVIORAL	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

Timeline

• Start date: 2020-11-02
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-09-08
• Last updated: 2026-02-23

Locations

1 site across 1 country: Canada