ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)
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|ClinicalTrials.gov Identifier: NCT02814903|
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||ALDOsterone for Prediction of Post-Operative Atrial Fibrillation|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
Planned cardiac surgery. POAF occurence or not
The ALDO-POAF study is an observational, 1-center and prospective pilot study that will enroll patients undergoing CABG ± aortic valve replacement. Patients who had emergency CABG, need for concomitant mitral surgery, left ventricular ejection fraction (LVEF) < 50%, a history of AF or other atrial arrhythmia, unstable angina or heart failure, cardiogenic shock, atrioventricular block, hypothyroidism/hyperthyroidism, previous heart surgery, and off-pump or on-pump beating CABG will be excluded.
- Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement) [ Time Frame: 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. [ Time Frame: 6 months ]
- Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels. [ Time Frame: 1 month ]
- Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation [ Time Frame: 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. [ Time Frame: 1 month ]
- Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
- Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
- Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
- Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
- Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
- Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality [ Time Frame: 2 years ]
- Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation [ Time Frame: 1 month ]
Biospecimen Retention: Samples Without DNA
- galectin 3
- right atrial sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814903
|Caen, Basse Normandie, France, 14000|
|Contact: Mathieu CHEQUEL, MD +33625342363 firstname.lastname@example.org|
|Contact: Pierre OLLITRAULT, MD +33624922671 email@example.com|