ALDOsterone for Prediction of Post-Operative Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ALDO-POAF  

Official title:

ALDOsterone for Prediction of Post-Operative Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02814903
• Other study ID #: A14-D05-VOL.20
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 27, 2016
• Start date: January 2014
• Est. completion date: August 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
France	Joachim ALEXANDRE	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)		1 month	No
Secondary	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	No
Secondary	Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.		1 month	No
Secondary	Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation		1 month	No
Secondary	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	No
Secondary	Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation		1 month	No
Secondary	Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation		1 month	No
Secondary	Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation		1 month	No
Secondary	Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation		1 month	No
Secondary	Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation		1 month	No
Secondary	Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality		2 years	No
Secondary	Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation		1 month	No