- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814903
ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Basse Normandie
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Caen, Basse Normandie, France, 14000
- Recruiting
- Joachim ALEXANDRE
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Contact:
- Mathieu CHEQUEL, MD
- Phone Number: +33625342363
- Email: chequel-m@chu-caen.fr
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Contact:
- Pierre OLLITRAULT, MD
- Phone Number: +33624922671
- Email: ollitrault-p@chu-caen.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months
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Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.
Time Frame: 1 month
|
1 month
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Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation
Time Frame: 1 month
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1 month
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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
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1 month
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Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation
Time Frame: 1 month
|
1 month
|
Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation
Time Frame: 1 month
|
1 month
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Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation
Time Frame: 1 month
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1 month
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Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation
Time Frame: 1 month
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1 month
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Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation
Time Frame: 1 month
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1 month
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Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality
Time Frame: 2 years
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2 years
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Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation
Time Frame: 1 month
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A14-D05-VOL.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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