Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05531474

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Led by Population Health Research Institute · Updated on 2026-02-23

200

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) of 30 kg/m2 or higher; OR BMI 30 to 34.9 kg/m2 with type 2 diabetes or age over 55 years
  • Age 18 years or older
  • High-risk cardiovascular disease, defined by any of the following: history of major coronary artery disease, left ventricular ejection fraction below 40%, heart failure with preserved ejection fraction and recent hospitalization or elevated heart failure markers, documented atrial fibrillation with stroke risk score of 2 or higher, history of any stroke, or documented peripheral arterial disease
Not Eligible

You will not qualify if you...

  • Hospital admission for heart failure, myocardial infarction, stroke, or coronary revascularization within 30 days before randomization
  • Percutaneous coronary intervention with a drug-eluting stent within 90 days before randomization
  • Pregnancy
  • Contraindication to bariatric surgery
  • Prior bariatric surgery except gastric banding
  • Life expectancy less than 2 years due to non-cardiovascular causes
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hamilton Health Sciences

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

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Research Team

J

Jorge Wong, MD, MPH, FRCPC

CONTACT

S

Sumathy Rangarajan, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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