Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial (BRAVE)

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Population Health Research Institute (PHRI)

Status

Enrolling

Conditions

Cardiovascular Complication
Bariatric Surgery Candidate

Treatments

Behavioral: Medical Weight Management
Procedure: Bariatric Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05531474
BRAVE-Full Trial

Details and patient eligibility

About

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥35 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body mass index ≥35 kg/m2
  • 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)

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,000 participants in 2 patient groups

Medical Weight Management
Active Comparator group
Description:
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.
Treatment:
Behavioral: Medical Weight Management
Bariatric Surgery
Experimental group
Description:
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. .
Treatment:
Procedure: Bariatric Surgery

Trial contacts and locations

0

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Central trial contact

Tara McCready

Data sourced from clinicaltrials.gov

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