ALDOsterone for Prediction of Post-Operative Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02814903
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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%)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement) 1 month
- Secondary Outcome Measures
Name Time Method 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 preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation 1 month 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
Trial Locations
- Locations (1)
Joachim ALEXANDRE
🇫🇷Caen, Basse Normandie, France