Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Bariatric Surgery Candidate Clinical Trial

— BRAVE  

Official title:

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531474
• Other study ID #: BRAVE-Full Trial
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: September 2022
• Source: Population Health Research Institute
• Contact: Tara McCready
• Phone: 905-297-3479
• Email: tara.mccready[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥35 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health, cardiac structure and function, genomics, proteomics and metabolomics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Body mass index =35 kg/m2

2. Age =18 years

3. High-risk CVD, defined as the presence of any one of the following:

1. 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)

2. Left ventricular ejection fraction (LVEF) < 40%

3. Heart failure with preserved ejection fraction (LVEF > 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) > 300 pg/ml or BNP > 100 pg/ml in the past 12 months

4. Documented atrial fibrillation (AF) with CHA2DS2-VASc =2 stroke risk score

5. History of any stroke

6. 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)

Exclusion Criteria:

1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization

2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.

3. Pregnancy

4. Contraindication to bariatric surgery

5. Prior bariatric surgery, other than gastric banding

6. Life expectancy <2 years from non-cardiovascular causes

7. Inability to provide informed consent

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cardiovascular Complication

Intervention

Procedure:
• Bariatric Surgery
Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.

Behavioral:
• Medical Weight Management
The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life assessed by EQ5D questionnaire		Through study completion, expected average of 6 years
Other	Change in quality of life assessed by Laval questionnaire		Through study completion, expected average of 6 years
Other	Change in weight		Through study completion, expected average of 6 years
Other	Number of hospital admissions irrespective of cause		Through study completion, expected average of 6 years
Other	Number of participants with a new cancer diagnosis		Through study completion, expected average of 6 years
Primary	Cardiovascular Outcomes	Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).	Through study completion, expected average of 6 years
Secondary	All-cause mortality		Through study completion, expected average of 6 years
Secondary	Cardiovascular mortality		Through study completion, expected average of 6 years
Secondary	Myocardial infarction		Through study completion, expected average of 6 years
Secondary	Stroke		Through study completion, expected average of 6 years
Secondary	Hospitalization for heart failure		Through study completion, expected average of 6 years
Secondary	New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines		Through study completion, expected average of 6 years
Secondary	New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring		Through study completion, expected average of 6 years
Secondary	Cost effectiveness analysis, measured in quality adjusted life years	Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management	Through study completion, expected average of 6 years