ongoing

For more information, please email: brave@phri.ca

BRAVE is testing whether metabolic (also known as bariatric) surgery versus medical weight management, in people living with obesity who also have cardiovascular disease including heart failure, arrhythmias, and past heart attacks and strokes, reduces cardiovascular complications.

Metabolic surgery is expected to reduce weight by 40 kg on average but may also make people healthier by improving obesity-related problems like sleep apnea, diabetes, and high blood pressure. There are also weight independent effects of surgery, such as effects on insulin, gut hormones, and microbiome, which are likely important to improving heart health.

The primary outcome is major cardiovascular events. Therefore, this trial will establish whether surgical obesity treatment can improve cardiac health.

In a subset of individuals, we are examining the impact on cardiac structure and function by echocardiography.

In the BRAVE-Mind substudy, we are testing the effect of metabolic surgery on mental health and cognitive function.

We will also explore mechanisms of changes after metabolic surgery through blood and urine samples.

BRAVE US collaborators with Salim Yusuf at Toronto investigators meeting, Jan. 28, 2023

BRAVE Overview_Design (download PDF) Yusuf BRAVE Qualitative_01-28-2023 Welbourne BRAVE UK Experience_01-28-2023 Yusuf BRAVE FRS Estimate_01-28-2023 Ertl BRAVE Germany Experience_01-28-2023 Wong BRAVE Canada Recruitment_01-28-2023
Study Type

Interventional - Procedure

Study Design

Open-label, parallel-arm RCT

NO. of Countries

6

NO. of Sites

50

NO. of Participants

1500

Study Period

2021 - 2029

Sponsor

PHRI

VIDEO: Patient recruitment for the BRAVE clinical trial (English)

VIDEO: Patient recruitment for the BRAVE clinical trial (French)

Canadian Institutes of Health Research

Population Health Research Institute

PSI Foundation

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