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ALDOsterone for Prediction of Post-Operative Atrial Fibrillation

ALDOsterone for Prediction of Post-Operative Atrial Fibrillation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02814903
Acronym
ALDO-POAF
Enrollment
500
Registered
2016-06-28
Start date
2014-01-31
Completion date
2017-08-31
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

aldosterone, cardiac surgery, atrial fibrillation, galectin-3, mitochondria, ngal, acute kidney failure, epicardial fat, right atrial sample

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.

Interventions

None listed

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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%)

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)1 month

Secondary

MeasureTime frame
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 fibrillation1 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 preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation1 month
Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation1 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 left atrial strain and occurrence of postoperative atrial fibrillation1 month
Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation1 month
Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality2 years
Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation1 month
Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026