SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Trial end date:
2029-01-01
Target enrollment:
Participant gender:
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).