A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.
研究概览
简要总结
Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MI (as defined by the universal definition of MI) at least 1 year before inclusion.
- •BMI ≥35 kg/m2
- •Written informed consent obtained
排除标准
- •Any condition that may influence the patient's ability to comply with study protocol.
- •Earlier MBS or operation for gastric or duodenal ulcer or reflux disease
- •Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist
- •Unable to understand Swedish.
结局指标
主要结局
MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.
时间窗: Through study completion, expected average of 6 years
Data will be obtained for the Swedish national patient registry and other national quality registries.
次要结局
- Remission of type 2 diabetes (T2D) and hypertension(Through study completion, expected average of 6 years)
- Myocardial infarction(Through study completion, expected average of 6 years)
- hospital admission because of atrial fibrillation as a primary ICD diagnosis.(Through study completion, expected average of 6 years)
- Stroke(Through study completion, expected average of 6 years)
- Myocardial revascularization (not related to MI)(Through study completion, expected average of 6 years)
- All-cause mortality(Through study completion, expected average of 6 years)
- Cardiovascular death(Through study completion, expected average of 6 years)
- hospital admission because of heart failure as a primary ICD diagnosis.(Through study completion, expected average of 6 years)
- Total event rate(Through study completion, expected average of 6 years)
研究者
Erik Näslund
Professor
Danderyd Hospital