Cardiometabolic & kidneyTrial design
Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of cardiovascular events (BRAVE) trial
- investigator-initiated, multi-center, open-label RCT with blinded endpoint adjudication
- randomized 1:1
- vanguard phase of 200 participants
Study context
- Population
- Adults with obesity and high-risk cardiovascular disease (CVD): body-mass index ≥35 kg/m² or ≥30 kg/m² with type 2 diabetes or age >55 years, and prior myocardial infarction (MI), coronary intervention, heart failure (HF), atrial fibrillation (AF) with elevated CHA₂DS₂-VASc score, cerebrovascular disease, or peripheral arterial diseaserandomized in the vanguard phase, 2,514 individuals screened from 17 centers, 444 entered metabolic/bariatric surgery (MBS) work-up
- Participants
- 200 adults
- Planned comparison
- MBS vs guideline-based medical weight management
- Primary endpoint
- Composite of:
- All-cause death
- MI
- Stroke
- HF events
- Coronary revascularization
- AF hospitalization
- Renal events
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Recruitment (vanguard phase) · As of October 2025
- Individuals screened from 17 centers in Canada, Brazil, Italy and Spain
- 2,514
- Entered MBS work-up
- 444
- Randomized
- 200
- Recruitment barriers were identified and addressed through targeted education and enhanced patient engagement
Baseline characteristics of the randomized cohort
- Mean age
- 59.8 years
- Female
- 37%
- Mean BMI
- 44.0 kg m⁻²
- Hypertension
- 82%
- Diabetes
- 45%
- Coronary artery disease
- 44%
- HF
- 39%
- AF
- 48%
Original publication
Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of cardiovascular events (BRAVE) trial. Am Heart J. Published 25 July 2026. doi:10.1016/j.ahj.2026.107544
Summarised from the published abstract; every number is checked against it