Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.

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.

Timeline

Start

2019-02-26

Primary completion

2021-07

Completion

2021-09

Publications

• Alexandre J, Ollitrault P, Fischer MO, Fellahi JL, Rozec B, Cholley B, Dolladille C, Chequel M, Allouche S, Legallois D, Saplacan V, Buklas D, Beygui F, Parienti JJ, Milliez P. Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial. Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

Drugs

Indications