Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial

NCT ID: NCT05531474

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2027-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Medical Weight Management

Intervention Type: BEHAVIORAL

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

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. .

Group Type: EXPERIMENTAL

Bariatric Surgery

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jorge Wong, MD, MPH, FRCPC

Role: CONTACT

jorge.wong@phri.ca

905-521-2100 ext. 40309

Sumathy Rangarajan, MSc

Role: CONTACT

sumathy.rangarajan@phri.ca

905-296-5792

Facility Contacts

Jorge Wong, MD

Role: primary

jorge.wong@phri.ca

905-527-4322 ext. 41149

Other Identifiers

BRAVE-Full Trial

Identifier Type: -

Identifier Source: org_study_id