Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Collaborator: Ministry of Health, France
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Male or female; Age ≥ 18 years

• On-pump elective CABG surgery ± AVR

• In sinus rhythm

• Patient signed consent

• Willing to comply with scheduled visits, as outlined in the protocol

• French nationality

• Recipients of the social security regime

Exclusion Criteria:

• Contraindications to spironolactone therapy: intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min. Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min), Severe liver dysfunction (Child-Pugh Class 3), patients treated by other potassium sparing medication (except in case of hypokalemia).

• Patients treated by MRA treatment (spironolactone or eplerenone)

• LVEF < 50% obtained within 6 months prior to V0

• Mitral valve surgery associated to the CABG

• Off-pump beating or emergent/urgent CABG

• History of AF or another atrial arrhythmia

• Presence of antiarrhythmic medication (other than β-blockers)

• Previous heart surgery and heart transplant recipient

• Unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock

• Patients included or planning to be included in another medical research protocol

• Patients unable to complete the protocol follow-up

• Pregnant or nursing women

• Adults with protective measures (curatorship or tutorship or safeguarding justice or juridical protection)