Heart failure & cardiomyopathies
The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF): Rationale and Design
Study context
- Population
- Patients with HFpEF/HFmrEF (LVEF ≥40%, elevated NT-proBNP, chronic loop diuretic use), Sweden (SwedeHF) and United States (US)planned ≈2400
- Planned comparison
- Spironolactone plus usual care vs usual care alone
- Primary endpoint
- Total number of cardiovascular deaths and hospitalizations for heart failure
Methodological detailsrationale and design, pragmatic, registry-based, multicentre, prospective, open-label, blinded endpoint, event-driven, Randomised 1:1, Outcomes from Swedish administrative registries and a US call centre, adjudicated, Enrolment over ≈6 years; power based on HRs from TOPCAT Americas subset
- Rationale and design
- Pragmatic
- Registry-based
- Multicentre
- Prospective
- Open-label
- Blinded endpoint
- Event-driven
- Randomised 1:1
- Outcomes from Swedish administrative registries and a US call centre, adjudicated
- Enrolment over ≈6 years; power based on HRs from TOPCAT Americas subset
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF): Rationale and Design. Eur J Heart Fail. Published 16 September 2024. doi:10.
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