Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Sep 4, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether bariatric surgery, a weight-loss surgery, can help reduce major heart problems in people who are severely obese and have a high risk of cardiovascular disease. The study will compare the outcomes of those who undergo bariatric surgery with those who follow a medical weight management program. In addition to looking at heart health, researchers will also explore how this surgery affects mental health and other factors related to heart function.

To be eligible for this trial, participants must be at least 18 years old, have a body mass index (BMI) of 35 or higher, and have specific heart issues that put them at high risk for serious cardiovascular problems. Participants can expect to be closely monitored throughout the study, and their health will be assessed in various ways to understand the full impact of the surgery. This study is currently recruiting participants, and it aims to provide valuable information about the safety and effectiveness of bariatric surgery in improving heart health.

Gender

ALL

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 \>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