Bariatric Surgery for Cardiovascular Complications
(BRAVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is bariatric surgery generally safe for humans?
How does bariatric surgery differ from other treatments for cardiovascular complications?
Bariatric surgery is unique because it not only helps achieve significant and lasting weight loss but also addresses obesity-related illnesses, including cardiovascular complications, by altering the digestive system to limit food intake and nutrient absorption. Unlike non-surgical weight management, it involves surgical procedures like gastric bypass and sleeve gastrectomy, which can lead to both early and late complications but offer a more permanent solution for morbid obesity.25678
What data supports the effectiveness of this treatment for cardiovascular complications?
Who Is on the Research Team?
Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC
Principal Investigator
Population Health Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with severe obesity (BMI ≥35 kg/m2) and high-risk cardiovascular disease, including heart failure, stroke history, or peripheral arterial disease. Candidates must not have had recent hospital admissions for heart issues or bariatric surgery (except gastric banding), be pregnant, or unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either bariatric surgery or medical weight management to reduce cardiovascular events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bariatric Surgery
- Medical Weight Management
Bariatric Surgery is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Population Health Research Institute
Lead Sponsor