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Trial record 28 of 221 for:    Aldosterone

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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Atrial Fibrillation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aldosterone

Group/Cohort
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.



Primary Outcome Measures :
  1. Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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 ]
  2. Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels. [ Time Frame: 1 month ]
  3. Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  4. 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 ]
  5. Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  6. Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  7. Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  8. Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  9. Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation [ Time Frame: 1 month ]
  10. Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality [ Time Frame: 2 years ]
  11. Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation [ Time Frame: 1 month ]

Biospecimen Retention:   Samples Without DNA
  • aldosterone
  • galectin 3
  • ngal
  • mitochondria
  • right atrial sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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. Approval for this study, including collection of human tissues (right atrial appendage, subcutaneous and epicardial fat) and blood collection, was obtained from the Ethics Committee of Caen University Hospital (Comité de Protection des Personnes Nord-Ouest III, Caen, France) and will be in accordance to the declaration of Helsinki; the details of the study will be explained to the subjects, and written informed consent will be obtained from each patient.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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France
Joachim ALEXANDRE Recruiting
Caen, Basse Normandie, France, 14000
Contact: Mathieu CHEQUEL, MD    +33625342363    chequel-m@chu-caen.fr   
Contact: Pierre OLLITRAULT, MD    +33624922671    ollitrault-p@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

Additional Information:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02814903     History of Changes
Other Study ID Numbers: A14-D05-VOL.20
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University Hospital, Caen:
aldosterone
cardiac surgery
atrial fibrillation
galectin-3
mitochondria
ngal
acute kidney failure
epicardial fat
right atrial sample
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes