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New treatment option for Cardiovascular Complication
Official title Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05531474
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 CVD, defined as the presence of any one of the following:
- High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50%...
- Left ventricular ejection fraction (LVEF) \< 40%
You likely can't join if
- 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
- Prior bariatric surgery, other than gastric banding
- Life expectancy \<2 years from non-cardiovascular causes
See the full eligibility criteria
- 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 CVD, defined as the presence of any one of the following:
- 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%
- 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...
- Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
- History of any stroke
- 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...
- 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
- Prior bariatric surgery, other than gastric banding
- Life expectancy \<2 years from non-cardiovascular causes
- Inability to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.