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Procedure
Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial (BRAVE Trial)
N/A
Waitlist Available
Led By Aristithes Doumouras, MD MPH FRCSC
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion (an average of 1.5 years follow-up)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether bariatric surgery (weight loss surgery) is better than medical weight management (diet and lifestyle changes) for people with high-risk cardiovascular disease.
Eligible Conditions
- Cardiovascular Disease
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion (an average of 1.5 years follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion (an average of 1.5 years follow-up)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Crossover rate
Recruitment rate
Time to intervention administration
Secondary study objectives
Change in 36-Item Short Form Survey (SF-36) questionnaire score at 1 year
Change in 6-minute walk test distance (m) at 1 year
Change in BMI at 1 year
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Medical Weight Management (MWM) corresponds to the standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care.
Group II: InterventionActive Control1 Intervention
Bariatric surgery will consist of laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy performed at the discretion of the surgeon and according to local standards.
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
339,869 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
202 Previous Clinical Trials
26,865 Total Patients Enrolled
Population Health Research InstituteOTHER
164 Previous Clinical Trials
718,454 Total Patients Enrolled
Aristithes Doumouras, MD MPH FRCSCPrincipal InvestigatorSt. Joseph's Healthcare, McMaster University
Jorge Wong, MD MPH FRCPCPrincipal InvestigatorPHRI, Hamilton Health Sciences, McMaster University