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Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Study acronym: BRAVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Enrollment increased: 200 → 700 participantsv4 Show 1 more changeShow less
    • Enrollment increased: 200 → 700 participants

    See this version in full on ClinicalTrials.gov ↗

  2. Study Identification, Study Status, Oversight, IPDSharingv3
  3. Enrollment target: 2000 to 200 Start date: Jun 30, 2022 to Nov 2, 2020 · Eligibility criteria expanded, about 18 wordsv2 Show 2 more changesShow less
    • Start date: Jun 30, 2022 to Nov 2, 2020
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05531474
Lead Sponsor Population Health Research Institute
Conditions Cardiovascular Complication, Bariatric Surgery Candidate
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov