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NOT YET RECRUITING

NCT06204640

PHASE3

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

Sponsor: University Hospital, Caen

View on ClinicalTrials.gov

Summary

Introduction: There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported. Therefore, investigators propose to perform a randomized, multicenter, open blinded end-point (PROBE) study to evaluate the efficacy of spironolactone on AF recurrence in hypertensive patients with preserved LVEF. Materials and methods: SPONSoR trial will be a multicenter, landmark, randomized, open blinded end-point (PROBE) trial of the MRA, spironolactone, in 580 hypertensive patients referred for AF with preserved LVEF. 580 patients will be randomized in a 1:1 ratio to either receive oral spironolactone once daily on top of standard therapy or standard therapy alone, started the day of randomization and continued for 12 months. Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. AF detection will be provided by the use of a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) throughout the duration of the study. These wearables optical PPG devices (ScanWatch 42mm®, Withings). The trial duration is 3 years (24 months for inclusion with 12 months of follow-up; total duration participation for the patient of 12 months).

Official title: SPironolactONe for the Maintenance of Sinus Rhythm in Hypertensive Patients With Atrial Fibrillation and Preserved Left Ventricular Ejection Fraction (SPONSoR Study).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2024-03-01

Completion Date

2029-01-01

Last Updated

2024-01-12

Healthy Volunteers

Conditions

Atrial Fibrillation Recurrent

Interventions

DRUG

Spironolactone

Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit.

Inclusion Criteria: * 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 Exclusion Criteria: * 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). * Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia * LVEF \< 40% obtained within 6 months prior to V0 * Planned atrial fibrillation ablation within 6 months after randomization * Moderate-to-severe valvular heart disease * Permanent AF or long-standing persistent AF as defined by the ESC guidelines * AF on the ECG at the inclusion visit * Previous left atrial ablation or previous maze or maze-like surgery * Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis) * Left atrium diameter \> 60 mm obtained within 6 months prior to V0 * Contraindication to oral anticoagulation therapy * 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 * 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