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Recruiting NCT05531474

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

No phase Interventional Cardiovascular Complication Bariatric Surgery Candidate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric Surgery, Medical Weight Management.
Who it may be relevant to
Registry conditions: Cardiovascular Complication, Bariatric Surgery Candidate. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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.
  • Behavioral 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 measures

  • Cardiovascular Outcomes [Time frame: Through study completion, expected average of 6 years]
  • BRAVE-Mind Sub-study Measures [Time frame: 3 years]
Secondary outcome measures (8)
  • All-cause mortality [Time frame: Through study completion, expected average of 6 years]
  • Cardiovascular mortality [Time frame: Through study completion, expected average of 6 years]
  • Myocardial infarction [Time frame: Through study completion, expected average of 6 years]
  • Stroke [Time frame: Through study completion, expected average of 6 years]
  • Hospitalization for heart failure [Time frame: Through study completion, expected average of 6 years]
  • 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]
  • New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring [Time frame: Through study completion, expected average of 6 years]
  • Cost effectiveness analysis, measured in quality adjusted life years [Time frame: Through study completion, expected average of 6 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Hamilton Health Sciences — Hamilton

Identifiers

NCT: NCT05531474 · BRAVE-Full Trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗