SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Korábbi kezelés

• Previous left atrial ablation or previous maze or maze-like surgery
• Left atrium diameter > 60 mm obtained within 6 months prior to V0
• Contraindication to oral anticoagulation therapy

Más betegség

• Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
• Moderate-to-severe valvular heart disease
• Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
• Patients with persistent bradycardia of less than 50 beats per minute, a PR interval of 0.2 second or more on ECG, second degree (or higher) atrioventricular block, and snus-node disease without an implanted pacemaker
• Hemodynamic instability and unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock

Laborértékek

• Contraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1,73m² (per the CKD-EPI equation). Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min/1,73m²), Severe liver dysfunction.
• Patients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone).
• LVEF < 40% obtained within 6 months prior to V0

Egyéb

• Planned atrial fibrillation ablation within 6 months after randomization
• Permanent AF or long-standing persistent AF as defined by the ESC guidelines
• AF on the ECG at the inclusion visit
• A life expectancy of 1 years or less
• Patients included or planning to be included in another medical research protocol whose pharmacological and scientific rationales might interfere with the Sponsor trial
• Patients unable to complete the protocol follow-up
• Pregnant or nursing women
• Adults with protective measures (curatorship or tutorship) and vulnerable patients

• Male or female (since spironolactone is not recommended during pregnancy and breastfeeding, a highly sensitive pregnancy test (serum HCG) will be systematically carried out in women of childbearing age and information will be given to non-pregnant women at the time of inclusion to instruct them to use an effective method of contraception during all the study period. Effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, or progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion or vasectomised partner, or sexual abstinence)
• Age > 18 years
• Hypertension defined as current use of anti-hypertensive drugs for more than 12 months
• Paroxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 6 months
• Sinus rhythm at enrolment
• Patient signed consent
• Willing to comply with scheduled visits, as outlined in the protocol
• French speaking
• Recipients of the social security regime