Spironolactone et fibrillation atriale survenant après chirurgie cardiaque : essai multicentrique randomisée en double aveugle

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-000263-92-FR
• Lead Sponsor: CHU CAE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-28
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1500

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified