Clinical trial NCT05531474: Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial
Official title: Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Complication
Bariatric Surgery Candidate
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 \&gt;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) \&lt; 40%
   3. Heart failure with preserved ejection fraction (LVEF \&gt; 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \&gt; 300 pg/ml or BNP \&gt; 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 \&lt;2 years from non-cardiovascular causes
7. Inability to provide informed consent

Primary outcomes:
measure: Cardiovascular Outcomes
timeFrame: Through study completion, expected average of 6 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, expected average of 6 years
measure: Cardiovascular mortality
timeFrame: Through study completion, expected average of 6 years
measure: Myocardial infarction
timeFrame: Through study completion, expected average of 6 years
measure: Stroke
timeFrame: Through study completion, expected average of 6 years
measure: Hospitalization for heart failure
timeFrame: Through study completion, expected average of 6 years
measure: New onset or remission of type 2 diabetes as per Diabetes Canada / American Diabetes Association Guidelines
timeFrame: Through study completion, expected average of 6 years
measure: New onset atrial fibrillation as assessed by ECG or heart rhythm monitoring
timeFrame: Through study completion, expected average of 6 years
measure: Cost effectiveness analysis, measured in quality adjusted life years
timeFrame: Through study completion, expected average of 6 years
Other outcomes:
measure: Change in quality of life assessed by EQ5D questionnaire
timeFrame: Through study completion, expected average of 6 years
measure: Change in quality of life assessed by Laval questionnaire
timeFrame: Through study completion, expected average of 6 years
measure: Change in weight
timeFrame: Through study completion, expected average of 6 years
measure: Number of hospital admissions irrespective of cause
timeFrame: Through study completion, expected average of 6 years
measure: Number of participants with a new cancer diagnosis
timeFrame: Through study completion, expected average of 6 years
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC
role: PRINCIPAL_INVESTIGATOR
References: