Cardiovascular ComplicationBRAVENCT05531474
Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
A study testing Bariatric Surgery and Medical Weight Management in people with Cardiovascular Complication and Bariatric Surgery Candidate, run by Population Health Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Complication, Bariatric Surgery Candidate
- What is being tested?
- Bariatric Surgery and Medical Weight Management
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2020to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are \>55 years of age
- Age ≥18 years
- High-risk CVD, defined as the presence of any one of the following:
- High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
- Left ventricular ejection fraction (LVEF) \< 40%
- Heart failure with preserved ejection fraction (LVEF \> 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \> 300 pg/ml or BNP \> 100 pg/ml in the past 12 months
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- Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
- History of any stroke
- Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)
Who cannot join
- Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
- Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
- Pregnancy
- Contraindication to bariatric surgery
- Prior bariatric surgery, other than gastric banding
- Life expectancy \<2 years from non-cardiovascular causes
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Jorge Wong, MD, 905-527-4322 ext. 41149, jorge.wong@phri.ca
About this study
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.
- Being tested
- Bariatric Surgery, Medical Weight Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or 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.
Medical Weight ManagementBehavioural
The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
| Study group | Role | What they receive |
|---|---|---|
| Medical Weight Management | Active comparator | MWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and/or behavioral modification counseling, which may include nutritional counseling, safe weight management and/or making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and/or anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines. Receives: Behavioral: Medical Weight Management |
| Bariatric Surgery | Experimental | The bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. . Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Outcomes
Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).
Measured: Through study completion, expected average of 6 years
BRAVE-Mind Sub-study Measures
- Depressive symptoms asessed with the Patient Health Questionnaire-8 (PHQ-8)
- Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA) Secondary Outcome Measures:
- Executive function and processing speed assessed with the Number Symbol Coding Task (NSCT)
- Functional capacity assessed with the Standardized Assessment of Global Activities in the Elderly (SAGE)
- Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 (GAD-7)
- Nonnormative eating symptoms assessed with the Loss of Control Over Eating-Brief (LOCES-B)
Measured: 3 years
Secondary outcomes (8)
All-cause mortality
Measured: Through study completion, expected average of 6 years
Cardiovascular mortality
Measured: Through study completion, expected average of 6 years
Myocardial infarction
Measured: Through study completion, expected average of 6 years
Stroke
Measured: Through study completion, expected average of 6 years
Hospitalization for heart failure
Measured: Through study completion, expected average of 6 years
New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines
Measured: Through study completion, expected average of 6 years
New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring
Measured: Through study completion, expected average of 6 years
Cost effectiveness analysis, measured in quality adjusted life years
Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management
Measured: Through study completion, expected average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start2 Nov 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531474
- Sponsor's protocol ID
- BRAVE-Full Trial
- Acronym
- BRAVE
- Status last verified
- May 2026
- First submitted
- 13 Jun 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong JA, Conen D, Doumouras A, Van Reekum E, Bangdiwala SI, Balasubramanian K, Bashir S, Rangarajan S, Piche ME, Pettigrew M, Agapay D, Maggioni AP, Stork S, Pajecki D, Davey RA, Kouz R, Villiard R, Dash S, Avezum A, Cohen R, Castaner O, Poirier P, Anvari M, Yusuf S. Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of cardiovascular events (BRAVE) trial. Am Heart J. 2026 Jul 25;302:107544. doi: 10.1016/j.ahj.2026.107544. Online ahead of print.
PubMed 42501951
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05531474
- Acronym / sponsor ID
- BRAVE / BRAVE-Full Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Weight Management | Active comparator | Behavioral: Medical Weight ManagementMWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and/or behavioral modification counseling, which may include nutritional counseling, safe weight management and/or making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and/or anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines. |
| Bariatric Surgery | Experimental | Procedure: Bariatric SurgeryThe bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are \>55 years of age
- Age ≥18 years
- High-risk CVD, defined as the presence of any one of the following:
Key exclusion criteria (7 listed)
- Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
- Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
- Pregnancy
- Contraindication to bariatric surgery
- Prior bariatric surgery, other than gastric banding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryBariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. | Procedure or surgery | Bariatric Surgery |
| Medical Weight ManagementThe current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care | Behavioural | Medical Weight Management |
Primary outcome
Cardiovascular Outcomes
Time frame: Through study completion, expected average of 6 years
Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).
BRAVE-Mind Sub-study Measures
Time frame: 3 years
1. Depressive symptoms asessed with the Patient Health Questionnaire-8 (PHQ-8) 2. Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA) Secondary Outcome Measures: 3. Executive function and processing speed assessed with the Number Symbol Coding Task (NSCT) 4. Functional capacity assessed with the Standardized Assessment of Global Activities in the Elderly (SAGE) 5. Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 (GAD-7) 6. Nonnormative eating symptoms assessed with the Loss of Control Over Eating-Brief (LOCES-B)
8 secondary outcomes
All-cause mortality
Time frame: Through study completion, expected average of 6 years
Cardiovascular mortality
Time frame: Through study completion, expected average of 6 years
Myocardial infarction
Time frame: Through study completion, expected average of 6 years
Stroke
Time frame: Through study completion, expected average of 6 years
Hospitalization for heart failure
Time frame: Through study completion, expected average of 6 years
New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines
Time frame: Through study completion, expected average of 6 years
New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring
Time frame: Through study completion, expected average of 6 years
Cost effectiveness analysis, measured in quality adjusted life years
Time frame: Through study completion, expected average of 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42501951Wong JA, Conen D, Doumouras A, Van Reekum E, Bangdiwala SI, Balasubramanian K, Bashir S, Rangarajan S, Piche ME, Pettigrew M, Agapay D, Maggioni AP, Stork S, Pajecki D, Davey RA, Kouz R, Villiard R, Dash S, Avezum A, Cohen R, Castaner O, Poirier P, Anvari M, Yusuf S. Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of cardiovascular events (BRAVE) trial. Am Heart J. 2026 Jul 25;302:107544. doi: 10.1016/j.ahj.2026.107544. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery and Medical Weight Management in people with Cardiovascular Complication and Bariatric Surgery Candidate, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Wong, MD, MPH, FRCPC (905-521-2100 ext. 40309, jorge.wong@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Outcomes (time frame: Through study completion, expected average of 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.