Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

NCT05531474 | Recruiting DMC

• 1 other identifier: BRAVE-Full Trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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, cardiac structure and function, genomics, proteomics and metabolomics.

Conditions

Cardiovascular Complication; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Outcomes

  Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).

  Through study completion, expected average of 6 years

Secondary Outcomes (8)

• All-cause mortality

  Through study completion, expected average of 6 years

• Cardiovascular mortality

  Through study completion, expected average of 6 years

• Myocardial infarction

  Through study completion, expected average of 6 years

• Stroke

  Through study completion, expected average of 6 years

• Hospitalization for heart failure

  Through study completion, expected average of 6 years

Other Outcomes (5)

• Change in quality of life assessed by EQ5D questionnaire

  Through study completion, expected average of 6 years

• Change in quality of life assessed by Laval questionnaire

  Through study completion, expected average of 6 years

• Change in weight

  Through study completion, expected average of 6 years

Study Arms (2)

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.

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. .

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.

Bariatric Surgery

Medical Weight Management BEHAVIORAL

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

Medical Weight Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Wong, MD, MPH, FRCPC

CONTACT

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

Sumathy Rangarajan, MSc

CONTACT

905-296-5792; sumathy.rangarajan@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: September 8, 2022
• Study Start: November 2, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CA (1)