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ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)

27. juni 2016 oppdatert av: University Hospital, Caen

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.

Studieoversikt

Status

Ukjent

Forhold

Atrieflimmer

Studietype

Observasjonsmessig

Registrering (Forventet)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- Basse Normandie
  - Caen, Basse Normandie, Frankrike, 14000
    - Rekruttering
    - Joachim ALEXANDRE
    - Ta kontakt med:
      
      Mathieu CHEQUEL, MD
      
      Telefonnummer: +33625342363
      
      E-post: chequel-m@chu-caen.fr
    - Ta kontakt med:
      
      Pierre OLLITRAULT, MD
      
      Telefonnummer: +33624922671
      
      E-post: ollitrault-p@chu-caen.fr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

Planned cardiac surgery. POAF occurence or not

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål	Tidsramme
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. Tidsramme: 6 months	6 months
Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels. Tidsramme: 1 month	1 month
Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation Tidsramme: 1 month	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. Tidsramme: 1 month	1 month
Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation Tidsramme: 1 month	1 month
Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation Tidsramme: 1 month	1 month
Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation Tidsramme: 1 month	1 month
Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation Tidsramme: 1 month	1 month
Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation Tidsramme: 1 month	1 month
Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality Tidsramme: 2 years	2 years
Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation Tidsramme: 1 month	1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Caen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Forventet)

1. juni 2017

Studiet fullført (Forventet)

1. august 2017

Datoer for studieregistrering

Først innsendt

14. juni 2016

Først innsendt som oppfylte QC-kriteriene

27. juni 2016

Først lagt ut (Anslag)

28. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)