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Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

NCT05531474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531474 on ClinicalTrials.gov