Spironolactone for heart failure with preserved ejection fraction (HFpEF) — treatment coordination
1/2 Clinical Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction Study (SPIRRIT-EX)
['FUNDING_OTHER'] · DUKE UNIVERSITY · NIH-11317290
This project compares starting spironolactone with usual care in adults who have heart failure with preserved ejection fraction to try to lower hospitalizations and deaths.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | DUKE UNIVERSITY (nih funded) |
| Locations | 1 site (DURHAM, UNITED STATES) |
| Trial ID | NIH-11317290 on ClinicalTrials.gov |
What this research studies
If you have HFpEF, this project helps run a large randomized effort testing whether starting spironolactone improves outcomes. Participants are randomly assigned to begin spironolactone or to receive usual care, and clinicians follow them over time for events such as heart-failure hospitalization, cardiac arrest, or death. The Duke coordinating center organizes participating sites, manages data and safety monitoring, and streamlines follow-up to include many patients with straightforward visits and record-based tracking. The goal is to run a simple, large trial that can provide clear results for people with HFpEF.
Who could benefit from this research
Good fit: Adults diagnosed with heart failure who have a preserved or near-normal left ventricular ejection fraction are the main candidates.
Not a fit: People with reduced ejection fraction, those with severe kidney disease, high potassium, other contraindications to spironolactone, or who are pregnant are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could reduce heart-failure hospitalizations, improve symptoms, and possibly lower death rates for people with HFpEF.
How similar studies have performed: The prior TOPCAT trial had mixed results—no improvement in the overall primary outcome but a reduction in heart-failure hospitalizations in regional analyses—so the approach has precedent but remains uncertain.
Where this research is happening
DURHAM, UNITED STATES
- DUKE UNIVERSITY — DURHAM, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: DEVORE, ADAM D — DUKE UNIVERSITY
- Study coordinator: DEVORE, ADAM D
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.