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NCT Number: NCT05531474

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

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.

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Key information

Conditions

Cardiovascular Complication Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location status: Recruiting

Location contact

Jorge Wong, MD

CONTACT

[email protected]

905-527-4322 ext. 41149

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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).

  2. BRAVE-Mind Sub-study Measures

    Time frame: 3 years

    • 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)

Secondary outcomes

  1. All-cause mortality

    Time frame: Through study completion, expected average of 6 years

  2. Cardiovascular mortality

    Time frame: Through study completion, expected average of 6 years

  3. Myocardial infarction

    Time frame: Through study completion, expected average of 6 years

  4. Stroke

    Time frame: Through study completion, expected average of 6 years

  5. Hospitalization for heart failure

    Time frame: Through study completion, expected average of 6 years

  6. 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

  7. New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring

    Time frame: Through study completion, expected average of 6 years

  8. Cost effectiveness analysis, measured in quality adjusted life years

    Time frame: Through study completion, expected average of 6 years

    Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management

Other outcomes

  1. Change in quality of life assessed by EQ5D questionnaire

    Time frame: Through study completion, expected average of 6 years

  2. Change in quality of life assessed by Laval questionnaire

    Time frame: Through study completion, expected average of 6 years

  3. Change in weight

    Time frame: Through study completion, expected average of 6 years

  4. Number of hospital admissions irrespective of cause

    Time frame: Through study completion, expected average of 6 years

  5. Number of participants with a new cancer diagnosis

    Time frame: Through study completion, expected average of 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Wong, MD, MPH, FRCPC

CONTACT

[email protected]

905-521-2100 ext. 40309

Sumathy Rangarajan, MSc

CONTACT

[email protected]

905-296-5792

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Acronym: BRAVE

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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