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Bariatric Surgery for Cardiovascular Complications (BRAVE Trial)

N/A
Recruiting
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, expected average of 6 years
Awards & highlights

BRAVE Trial Summary

This trial is testing if bariatric surgery is better than medical weight management for reducing the risk of major cardiovascular events in obese people with high-risk cardiovascular disease. The cost-effectiveness of surgery will also be examined.

Who is the study for?
This trial is for adults with severe obesity (BMI ≥35 kg/m2) and high-risk cardiovascular disease, including heart failure, stroke history, or peripheral arterial disease. Candidates must not have had recent hospital admissions for heart issues or bariatric surgery (except gastric banding), be pregnant, or unable to consent.Check my eligibility
What is being tested?
The study compares the effectiveness of bariatric surgery versus medical weight management in reducing major cardiovascular events in severely obese patients with high-risk CVD. It also assesses the cost-effectiveness and impact on mental health and cardiac function.See study design
What are the potential side effects?
Potential side effects from bariatric surgery can include nutritional deficiencies, gastrointestinal problems like nausea and vomiting, surgical complications such as infections or bleeding, and changes in mental health.

BRAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of serious heart disease.
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I have had surgery or amputation due to poor blood flow in my limbs or have significant narrowing of my arteries.
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I have had a stroke before.
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I am 18 years old or older.
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I have atrial fibrillation with a stroke risk score of 2 or higher.

BRAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, expected average of 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, expected average of 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiovascular Outcomes
Secondary outcome measures
All-cause mortality
Cardiovascular mortality
Cost effectiveness analysis, measured in quality adjusted life years
+5 more
Other outcome measures
Change in quality of life assessed by EQ5D questionnaire
Change in quality of life assessed by Laval questionnaire
Change in weight
+2 more

BRAVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bariatric SurgeryExperimental Treatment1 Intervention
The bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. .
Group II: Medical Weight ManagementActive Control1 Intervention
MWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and/or behavioral modification counseling, which may include nutritional counseling, safe weight management and/or making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and/or anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric Surgery
2016
Completed Phase 3
~14180

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
154 Previous Clinical Trials
677,812 Total Patients Enrolled

Media Library

Bariatric Surgery Clinical Trial Eligibility Overview. Trial Name: NCT05531474 — N/A
Bariatric Surgery Candidates Research Study Groups: Medical Weight Management, Bariatric Surgery
Bariatric Surgery Candidates Clinical Trial 2023: Bariatric Surgery Highlights & Side Effects. Trial Name: NCT05531474 — N/A
Bariatric Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05531474 — N/A

Frequently Asked Questions

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

Are there still opportunities available for prospective participants in this research?

"Affirmative, clinicaltrials.gov posts confirm that 2000 individuals are being sought for the medical trial which began on June 30th 2022 and was last modified on September 4th 2021 at a single site."

Answered by AI

How many participants are participating in this trial?

"Affirmative. Per the information available on clinicaltrials.gov, this medicine trial is currently seeking participants and was initially posted in June of 2022 with a recent update made in September of that year. 2000 patients need to be recruited from one location for successful completion of the study."

Answered by AI
~1300 spots leftby Jul 2027