NCT06204640: SPONSoR

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

Not yet recruiting Phase 3 Last updated 12 January 2024

What this trial tests

Phase 3 trial testing Spironolactone in Atrial Fibrillation Recurrent in 580 participants. Not yet recruiting.

Timeline

1 March 2024

Primary endpoint
1 January 2028

1 January 2029

Quick facts

Lead sponsor	University Hospital, Caen
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	580
Start date	1 March 2024
Primary completion	1 January 2028
Estimated completion	1 January 2029

Drugs / interventions tested

• Spironolactone (spironolactone) — full drug profile →

Conditions studied

• Atrial Fibrillation Recurrent — all drugs for Atrial Fibrillation Recurrent →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Atrial Fibrillation Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.