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
Qualifiers
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
Treatments tested in this trial
- Bariatric Surgery
- Medical Weight Management
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov