Patients > 18 years referred for elective cardiac bypass graft (CABG) surgery ± aortic valve replacement (AVR) without any systolic heart failure or any mitral surgery associated MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: SPIRONOLACTONE
Product Name: SPIRONOLACTONE
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
CHU CAEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female; Age > 18 years 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500
Exclusion criteria
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 (per the Modification of Diet in Renal Disease (MDRD) 4-component study equation). 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) Left ventricular ejection fraction < 50% obtained within 6 months prior to V0 Mitral valve surgery associated to the CABG Off-pump beating or emergency CABG History of AF or another atrial arrhythmia Presence of antiarrhythmic medication (other than ß-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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 elective CABG ± AVR without heart failure;Secondary Objective: To evaluate whether perioperative administration of spironolactone affects: -Post-operative AF occurring from cardiac surgery and within 5 days after surgery, - Perioperative myocardial injury within 2 days after surgery (assessed by serial Troponin measurements at day 0 immediately after surgery, day 1 and 2 after surgery) - Major cardiovascular events and death (all-cause mortality, stroke, myocardial infarction, heart failure) occurring within 30 days of surgery, - Hospital and intensive care unit stay, - Need for readmission, - Left ventricular ejection fraction at discharge (from both ICU and hospital), - Ventricular arrhythmia occurring from cardiac surgery and within 5 days after surgery, - Blood pressure, serum potassium levels and renal function within 30 days of surgery. To evaluate whether the Aldoscore and the Aldoscore II could predict POAF occurrence, cardiovascular complications and mortality occurring within 30 days of surgery ;Primary end point(s): The primary judgment criteria is the 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 monitoring (during the conventional hospitalization stay).;Timepoint(s) of evaluation of this end point: 5 days after cardiac surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *The secondary judgment criteria related to spironolactone impact are: -Post-operative AF occurrence from cardiac surgery and within 5 days after CABG surgery (+/- AVR), -Evaluation of perioperative myocardial injury within 2 days after surgery, as assessed by serial measurements of the cardiac troponin I concentration at day 0 immediately after surgery, day 1 and 2 after surgery, -Occurrence of major cardiovascular events and death (death from any cause, stroke, heart failure, myocardial infarction) occurring within 30 days after surgery, -Duration of ICU and hospital stay, -Need for readmission, -Evaluation of the left ventricular ejection fraction at discharge (from both ICU and hospital), -Ventricular arrhythmia occurring from cardiac surgery and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter monitoring (during the conventional hospitalization stay), -Occurrence of low blood pressure, changes in serum potassium and acute kidney injury within 30 days after surgery. *Ability of the Aldoscore and the Aldoscore II to predict POAF and cardiovascular complications and mortality: Blood peripheral collection tubes will be collect during the anaesthesiologist outpatient visit with the patients resting quietly in a semi-recumbent position at least 10 min. Aldosterone levels will be centrally measured in the biochemistry department of the Caen University Hospital. Then, Aldoscore and Aldoscore II will be calculated as follows -8.3217 + 0.0842 x Age + 0.00729 x Aldosterone level. ;Timepoint(s) of evaluation of this end point: 30 days after cardiac surgery | — |
Countries
France
Contacts
Public ContactInvestigateur coordinateur
CHU CAEN
Outcome results
None listed