Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Cardiovascular Complication; Bariatric Surgery Candidate

• Registration Number: NCT05531474
• Lead Sponsor: Population Health Research Institute

Brief Summary

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, cardiac structure and function, genomics, proteomics and metabolomics.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-09-04
• Study First Posted: 2022-09-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiovascular Outcomes	Through study completion, expected average of 6 years	Composite of cardiovascular mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HF).

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Through study completion, expected average of 6 years
Myocardial infarction	Through study completion, expected average of 6 years
Cardiovascular mortality	Through study completion, expected average of 6 years
Stroke	Through study completion, expected average of 6 years
New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring	Through study completion, expected average of 6 years
Cost effectiveness analysis, measured in quality adjusted life years	Through study completion, expected average of 6 years	Economic evaluation to compare the costs and health outcomes associated with bariatric surgery and medical weight management
New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines	Through study completion, expected average of 6 years
Hospitalization for heart failure	Through study completion, expected average of 6 years

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada