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Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial.

Author information

1
Department of Pharmacology, CHU de Caen, Caen, F-14000, France; Université Caen Normandie, Medical School, UNICAEN, CHU Caen, EA, 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, Caen F-14000, France. Electronic address: alexandre-j@chu-caen.fr.
2
Department of Cardiology, CHU de Caen, Caen, F-14000, France.
3
Université Caen Normandie, Medical School, UNICAEN, CHU Caen, EA, 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, Caen F-14000, France; Pôle Réanimations Anesthésie SAMU/SMUR, CHU de Caen, Caen, F-14000, France.
4
Service d'Anesthésie-Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, 59 Boulevard Pinel, Lyon Cedex 03, France.
5
Service d'Anesthésie-Réanimation, Hôpital Laënnec, Centre, Hospitalier Universitaire, Nantes, France.
6
Anesthesiology and Critical Care Medicine Department, Hôpital Européen Georges Pompidou, AP-, HP, and Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
7
Department of Pharmacology, CHU de Caen, Caen, F-14000, France; Department of Cardiology, CHU de Caen, Caen, F-14000, France.
8
Université Caen Normandie, Medical School, UNICAEN, CHU Caen, EA, 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, Caen F-14000, France; Department of Biochemistry, CHU de Caen, Caen, F-14000, France.
9
Université Caen Normandie, Medical School, UNICAEN, CHU Caen, EA, 4650, Signalisation, électrophysiologie et imagerie des lésions d'ischémie-reperfusion myocardique, Caen F-14000, France; Department of Cardiology, CHU de Caen, Caen, F-14000, France.
10
Department of Cardiac Surgery, CHU de Caen, Caen, F-14000, France.
11
Department of Biostatistics and Clinical Research, CHU de Caen, Caen, F-14000, France; Medical School, Université Caen Normandie, UNICAEN, CHU, Caen, EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Caen, F-14000, France.

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).

STUDY DESIGN:

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.

PMID:
31174055
DOI:
10.1016/j.ahj.2019.04.023

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