SPironolactONe for the maintenance of Sinus Rhythm in hypertensive patients with atrial fibrillation and preserved left ventricular ejection fraction: a Prospective Randomized Open Blinded End-point (PROBE) multicenter study (SPONSoR study).

Prior treatment

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

Other illness

• □ Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
• □ Patients with persistent bradycardia of less than 50 beats per minute or a PR interval of 0.2 second or more on ECG, or second degree (or higher) atrioventricular block, or sinus-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
• □ Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
• □ Moderate-to-severe valvular heart disease

Lab values

• □ Contraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (≥ 5 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 50 ml/min/1,73m² (per the CKD-EPI equation). 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

Other

• □ 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
• □ 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

• □ 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)
• □ Recipients of the social security regime
• □ 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 12 months
• □ Sinus rhythm at enrolment
• □ Patients with a smartphone (Android or iPhone)
• □ Patient signed consent
• □ Willing to comply with scheduled visits, as outlined in the protocol
• □ French speaking