Intervention for Cardiovascular Disease (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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion (an average of 1.5 years follow-up) for reporting.

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 more

Awards & 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.

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