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Procedure

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

BRAVE Trial 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

BRAVE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Crossover rate

Recruitment rate

Time to intervention administration

Secondary outcome measures

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

BRAVE 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,933 Total Patients Enrolled

Population Health Research InstituteOTHER

155 Previous Clinical Trials

679,852 Total Patients Enrolled

St. Joseph's Healthcare HamiltonOTHER

196 Previous Clinical Trials

25,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project seeking participants currently?

"The clinical trial is still in the process of recruiting patients, as evidenced by its listing on clinicialtrials.gov which was created on October 30th 2020 and updated last March 14th 2022."

Answered by AI

What is the overall participation figure for this clinical research?

"Confirmative. According to clinicaltrials.gov, this research is currently recruiting patients who meet the eligibility criteria; it was launched on October 30th 2020 with its latest update occurring in March 14th 2022. The trial requires 60 participants at a single site."

Answered by AI

What anticipated results is the research team hoping to achieve?

"The primary evaluation of this trial is focused on the recruitment rate over 30 days. Secondary outcomes are changes in BMI and weight at 1 year, as well as a composite measure encompassing cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial

2020. "Bariatric Surgery for the Reduction of cArdioVascular Events Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04226664.

All > Cardiovascular