Bariatric surgery to reduce cardiovascular events in obese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of bariatric surgery compared to medical weight management in patients with severe obesity and high-risk cardiovascular disease. It aims to determine if bariatric surgery can safely reduce the risk of major cardiovascular events. Additionally, the study will explore the cost-effectiveness of the surgery and conduct sub-studies on its impact on mental health, cardiac structure and function, as well as genomics, proteomics, and metabolomics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
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

Where it's running

• Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC — Population Health Research Institute
• Study coordinator: Jorge Wong, MD, MPH, FRCPC
• Email: jorge.wong@phri.ca
• Phone: 905-521-2100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.