Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
About this trial
The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 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 and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are >55 years of age
Age ≥18 years
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)
Left ventricular ejection fraction (LVEF) < 40%
Disqualifiers
Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
Pregnancy
Contraindication to bariatric surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Bariatric Surgery
Procedure/SurgeryBariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.
Medical Weight Management
BehavioralThe current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Medical Weight ManagementActive comparator 1 intervention
Group B: Bariatric SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cardiovascular Outcomes
Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).
Time frame
Through study completion, expected average of 6 years2
BRAVE-Mind Sub-study Measures
1. Depressive symptoms asessed with the Patient Health Questionnaire-8 (PHQ-8) 2. Global cognitive function assessed with the Montreal Cognitive Assessment (MoCA) Secondary Outcome Measures: 3. Executive function and processing speed assessed with the Number Symbol Coding Task (NSCT) 4. Functional capacity assessed with the Standardized Assessment of Global Activities in the Elderly (SAGE) 5. Anxiety symptoms assessed with the Generalized Anxiety Disorder-7 (GAD-7) 6. Nonnormative eating symptoms assessed with the Loss of Control Over Eating-Brief (LOCES-B)
Time frame
3 yearsSecondary outcomes
1
All-cause mortality
Time frame
Through study completion, expected average of 6 years2
Cardiovascular mortality
Time frame
Through study completion, expected average of 6 years3
Myocardial infarction
Time frame
Through study completion, expected average of 6 years4
Stroke
Time frame
Through study completion, expected average of 6 yearsOther outcomes
1
Change in quality of life assessed by EQ5D questionnaire
Time frame
Through study completion, expected average of 6 years2
Change in quality of life assessed by Laval questionnaire
Time frame
Through study completion, expected average of 6 years3
Change in weight
Time frame
Through study completion, expected average of 6 years4
Number of hospital admissions irrespective of cause
Time frame
Through study completion, expected average of 6 yearsSponsors and contacts
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Source ClinicalTrials.gov