Recruiting

Bariatric Surgery

Sponsor:

Population Health Research Institute

Code:

NCT05531474

Conditions

Cardiovascular Complication

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bariatric Surgery

Medical Weight Management

Study Details

Brief 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.

Conditions

Cardiovascular Complication

Bariatric Surgery Candidate

Study ID

NCT05531474

Start date

Nov 2, 2020

Status verified date

May, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Age ≥18 years
3. High-risk CVD, defined as the presence of any one of the following:

1. 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)
2. Left ventricular ejection fraction (LVEF) \< 40%
3. 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
4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
5. History of any stroke
6. 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)

Exclusion Criteria:

1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
3. Pregnancy
4. Contraindication to bariatric surgery
5. Prior bariatric surgery, other than gastric banding
6. Life expectancy \<2 years from non-cardiovascular causes
7. Inability to provide informed consent

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medical Weight Management

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.

experimental: Bariatric Surgery

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. .

Interventions

Bariatric 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 Management

The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care

Primary outcome measure

  • Cardiovascular Outcomes [ Time Frame: Through study completion, expected average of 6 years ]
  • BRAVE-Mind Sub-study Measures [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Jorge Wong, MD, MPH, FRCPC

905-521-2100jorge.wong@phri.ca

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

More Information

Sponsor

Population Health Research Institute

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2026-05-28.