Atrial FibrillationALDO-POAFNCT02814903
ALDOsterone for Prediction of Post-Operative Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Joachim ALEXANDRE
Caen, Basse Normandie, 14000
Mathieu CHEQUEL, MD, +33625342363, chequel-m@chu-caen.fr
Pierre OLLITRAULT, MD, +33624922671, ollitrault-p@chu-caen.fr
About this study
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.
- Conditions
- Atrial Fibrillation
- Keywords
- aldosterone, cardiac surgery, atrial fibrillation, galectin-3, mitochondria, ngal, acute kidney failure, epicardial fat, right atrial sample
- Medical subject headings
- Atrial Fibrillation, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
Measured: 1 month
Secondary outcomes (11)
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.
Measured: 6 months
Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.
Measured: 1 month
Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation
Measured: 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.
Measured: 1 month
Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation
Measured: 1 month
Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation
Measured: 1 month
Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation
Measured: 1 month
Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation
Measured: 1 month
Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation
Measured: 1 month
Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality
Measured: 2 years
Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814903
- Sponsor's protocol ID
- A14-D05-VOL.20
- Acronym
- ALDO-POAF
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ollitrault P, Allouche S, Chequel M, Milliez P, Alexandre J. Plasma aldosterone and atrial mitochondrial functions of patients undergoing cardiac surgery. Future Cardiol. 2020 Jul;16(4):275-280. doi: 10.2217/fca-2019-0028. Epub 2020 Apr 14.
PubMed 32286862
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALDOsterone for Prediction of Post-Operative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02814903
- Acronym / sponsor ID
- ALDO-POAF / A14-D05-VOL.20
- Conditions
- Atrial Fibrillation
- Keywords
- aldosterone, cardiac surgery, atrial fibrillation, galectin-3, mitochondria, ngal, acute kidney failure, epicardial fat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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%)
Key exclusion criteria (14 listed)
- Patient having already AF history
- Patient with primary hyperaldosteronism
- Unstable Patient defined as any cardiovascular event occurred in the previous 30 days
- hospitalisation for cardiovascular causes
- appearance or worsening of symptoms consistent with cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
Time frame: 1 month
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 32286862Ollitrault P, Allouche S, Chequel M, Milliez P, Alexandre J. Plasma aldosterone and atrial mitochondrial functions of patients undergoing cardiac surgery. Future Cardiol. 2020 Jul;16(4):275-280. doi: 10.2217/fca-2019-0028. Epub 2020 Apr 14.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.