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Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
NCT02901184 · View on ClinicalTrials.gov ↗
Study Summary
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 test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of CV mortality and HF hospitalization as follows: Population: HFPEF patients in the Swedish Heart Failure Registry and HFPEF patients in US. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF\>=40%. Intervention and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care alone. Outcome: Primary outcome cardiovascular death or time to HF hospitalization. Secondary outcomes include hospitalization for various causes, adverse events and treatment adherence. In Sweden outcomes are obtained automatically by linking with the Population, Patient and Drug Dispensed Registries. In the US, outcomes will be reported by sites and supplemented by data from a call center. The trial is event-driven with enrollment 7 years and study duration 9 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 721 events the sample size requires 1985 patients conservatively rounded to approximately 2000 patients.
Conditions Studied
Interventions
- OTHER Standard care
- DRUG Spironolactone
Study Locations (20)
Illinois
- Fox Valley Clinical Research Center, LLC — Aurora
- University of Illinois at Chicago — Chicago
- Alexian Brothers Medical Center — Elk Grove Village
- Methodist Medical Center of Illinois — Peoria
Massachusetts
- Brigham and Women's Hospital — Boston
- Pentucket Medical Associates — Haverhill
- Charles River Medical Associates — Natick
- Newton-Wellesley Hospital — Newton
Alabama
- Advanced Cardiovascular LLC — Alexander City
- University of Alabama at Birmingham — Birmingham
District of Columbia
- MedStar Cardiovascular Research Network — Washington D.C.
- Howard University Hospital — Washington D.C.
Georgia
- Piedmont Atlanta Hospital — Atlanta
- Wellstar Health System, Inc. — Marietta
Arizona
- Banner - University Medical Group — Tucson
Florida
- Holy Cross Hospital — Fort Lauderdale
Hawaii
- Queens Medical Center — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2017-11-23 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02901184
The ClinicalTrials.gov registry entry for NCT02901184 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uppsala University, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions — of which Standard care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02901184 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Illinois, Massachusetts, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02901184 about?
NCT02901184 is a clinical study titled "Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction". 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...
What is the current status of trial NCT02901184?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,000 participants. The study started on 2017-11-23. Estimated completion is 2026-12.
What conditions does trial NCT02901184 study?
This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02901184?
The interventions under investigation include: Standard care (OTHER), Spironolactone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02901184?
This trial is sponsored by Uppsala University, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02901184 being conducted?
This trial has 20 study locations across Alabama, Arizona, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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