Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial.
Am Heart J
; 214: 88-96, 2019 08.
Article
en En
| MEDLINE
| ID: mdl-31174055
ABSTRACT
BACKGROUND:
After artery bypass grafting (CABG), the presence of perioperative AF (POAF) is associated with greater short- and long-term cardiovascular morbidity. Underlying POAF mechanisms are complex and include the presence of an arrhythmogenic substrate, cardiac fibrosis and electrical remodeling. Aldosterone is a key component in this process. We hypothesize that perioperative mineralocorticoid receptor (MR) blockade may decrease the POAF incidence in patients with a left ventricular ejection fraction (LVEF) ≥50% who are referred for CABG with or without aortic valve replacement (AVR). STUDYDESIGN:
The ALDOCURE trial (NCT03551548) will be a multicenter, randomized, double-blind, placebo-controlled trial testing the superiority of a low-cost MR antagonist (MRA, spironolactone) on POAF in 1500 adults referred for on-pump elective CABG surgery with or without AVR, without any history of heart failure or atrial arrhythmia. The primary efficacy end point is the occurrence of POAF from randomization to within 5 days after surgery, assessed in a standardized manner. The main secondary efficacy end points include the following postoperative AF occurring within 5 days after cardiac surgery, perioperative myocardial injury, major cardiovascular events and death occurring within 30 days of surgery, hospital and intensive care unit length of stay, need for readmission, LVEF at discharge and significant ventricular arrhythmias within 5 days after surgery. Safety end points, including blood pressure, serum potassium levels and renal function, will be monitored regularly throughout the trial duration.CONCLUSION:
The ALDOCURE trial will assess the effectiveness of spironolactone in addition to standard therapy for reducing POAF in patients undergoing CABG. CLINICAL TRIAL REGISTRATION NCT03551548.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Complicaciones Posoperatorias
/
Fibrilación Atrial
/
Espironolactona
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Puente de Arteria Coronaria
/
Antagonistas de Receptores de Mineralocorticoides
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Am Heart J
Año:
2019
Tipo del documento:
Article