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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, expected average of 6 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, expected average of 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, expected average of 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiovascular Outcomes
Secondary study objectives
Cost effectiveness analysis, measured in quality adjusted life years
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
164 Previous Clinical Trials
716,514 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have weight loss surgery due to health risks.I have had surgery or amputation due to poor blood flow in my limbs or have significant narrowing of my arteries.I have had a stroke before.I am 18 years old or older.I have atrial fibrillation with a stroke risk score of 2 or higher.I was hospitalized for heart failure, heart attack, stroke, or heart surgery within the last 30 days.I have had weight loss surgery, but not the gastric band type.I had a procedure to open my heart's arteries using a special stent within the last 3 months.I have a history of serious heart disease.I have heart failure but my heart still pumps well, and I've been hospitalized for it or had high heart stress levels recently.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Weight Management
- Group 2: Bariatric Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.