ALDOsterone for Prediction of Post-Operative Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
研究概览
简要总结
Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring after cardiac surgery, contributing to prolonged intensive care and hospital stays and is associated with several cardiovascular complications. The exact mechanisms and signaling pathways involved in the development of POAF seem to be multifactorial and remain to date incompletely understood. β-blockers and amiodarone are the first line preventive drugs but are partially effective and near 30% of POAF resist to these strategies. In this context, there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3 (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could be very useful predictive biomarkers of POAF and potentially interesting therapeutic target to prevent POAF occurrence.
The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3 (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive of POAF in patients undergoing elective CABG surgery with preserved LVEF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized for planned surgical coronary revascularization +/- aortic replacement valve
- •Aged 18 years at least
- •Clinically Stable (see criteria for non-inclusion)
- •With left ventricular ejection fraction preserved (>50%)
排除标准
- •Patient having already AF history
- •Patient with primary hyperaldosteronism
- •Unstable Patient defined as any cardiovascular event occurred in the previous 30 days
- •These events are:
- •hospitalisation for cardiovascular causes
- •appearance or worsening of symptoms consistent with cardiac failure
- •appearance or worsening symptoms of coronary
- •Patient refusing participation in the study
- •Patient unable to provide follow-up visits
- •need for concomitant mitral surgery
- •Emergency CABG
- •Left ventricular ejection fraction (LVEF) < 50%
- •Previous heart surgery
- •Off pump CABG.
结局指标
主要结局
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
时间窗: 1 month
次要结局
- Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation(1 month)
- Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation(1 month)
- Find a correlation between the local secretion of aldosterone by adipocytes epicardial and the occurrence of AF during the 6 months after surgery in patients undergoing cold bypass coronary artery.(6 months)
- Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.(1 month)
- Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation(1 month)
- Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation(1 month)
- Detect aldosterone synthase aldosterone or angiotensin II (measured by quantitative and qualitative assays Western Blot, mRNA or RT-PCR) in the epicardial fat removed during surgery in patients undergoing a CABG.(1 month)
- Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation(1 month)
- Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation(1 month)
- Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation(1 month)
- Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality(2 years)