Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF) is a Registry-based Randomized Clinical Trial (RRCT) designed to assess whether the initiation of spironolactone plus standard care compared to standard care alone improves outcomes in patients with Heart Failure with Preserved Ejection Fraction (HFpEF).
Methodology:
A 1:1 randomized, interventional, multicenter, safety/efficacy, parallel assignment, open-label treatment study using the RRCT methodology.
Intervention arm: Treatment with Spironolactone combined with usual care. Control arm: Usual care alone.
Number of patients (planned):
A number of 3200 eligible patients meeting the inclusion and exclusion criteria for the trial, included in the Swedish Heart Failure Registry (SwedeHF) and in the United States over a period of three years.
Diagnosis:
Heart Failure with Preserved Ejection Fraction (HFpEF)
Duration of treatment:
Minimum two (2) and up to five (5) years
Active control, dosage and mode of administration:
No active control
Planned study period:
Enrollment period 2017-2020 (3 years) and then follow up until 2022 (anticipated 5 years study duration).