Clinical Trial

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Study acronym: BRAVE
Recruiting
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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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-05-29
notable Enrollment increased: 200 -> 700 participants 2026-05-29
Trial Details
NCT Number NCT05531474
Lead Sponsor Population Health Research Institute
Conditions Cardiovascular Complication, Bariatric Surgery Candidate
Enrollment 700 participants
Start Date 2020-11-02
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-28