Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Recruiting
Phase 3
Interventional Study
Heart Failure With Preserved Ejection Fraction
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,000 (estimated)
- Sponsor
- Uppsala University · Other
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About This Trial
Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but it is generic and will not be studied by industry.
SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will te…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Written informed consent
* Age ≥50 years
* Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
* Left ventricular ejection fraction (LVEF) ≥40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or ≥50% group)
*…
Contacts