Bariatric surgery to reduce cardiovascular events in obese patients
Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
This study tests if bariatric surgery can help people with severe obesity and heart disease lower their risk of serious heart problems better than just medical weight management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05531474 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a BMI of 30 kg/m2 or higher and high-risk cardiovascular disease.
Not a fit: Patients who are not severely obese or do not have high-risk cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of cardiovascular events in obese patients with existing heart conditions.
How similar studies have performed: Previous studies have shown promising results for bariatric surgery in improving cardiovascular outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamilton, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.