Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.
Status:
Unknown status
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative
atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft
surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral
surgery.
Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5
days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during
the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay).
Primary objective: To establish whether pre-operative administration of spironolactone leads
to a reduction in POAF incidence occurring from randomization and within 5 days after
surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR
without heart failure.
Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective
study.