Spironolactone initiation registry for adults with heart failure and preserved ejection fraction (HFpEF)
2/2 Data Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction Study (SPIRRIT-EX)
This project looks at whether starting spironolactone helps adults with heart failure who have normal or near-normal heart pumping function (HFpEF).
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project ID | NIH-11090341 on NIH RePORTER |
What this research studies
You would be enrolled in a large registry and randomly assigned to start spironolactone or to usual care, with some masking to treatment. Duke's coordinating center will handle enrollment, data collection, safety checks, and analysis across participating hospitals. Doctors will follow you over time for events like heart-failure hospitalizations, cardiovascular death, and serious heart rhythm problems. The trial is designed to be simple and fit into routine care so the results apply to patients like you.
Who could benefit from this research
Good fit: Ideal candidates are adults (21+) diagnosed with heart failure with preserved or near-normal ejection fraction who can safely take spironolactone and attend follow-up visits.
Not a fit: People with reduced ejection fraction, those with contraindications to spironolactone (like severe kidney disease or high potassium), or those unable to attend follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could lower heart-failure hospitalizations and improve outcomes for people with HFpEF by clarifying the value of spironolactone.
How similar studies have performed: A prior large trial (TOPCAT) showed mixed results—no overall reduction in the primary composite outcome but fewer heart-failure hospitalizations and variable regional findings—so the approach has some supporting but inconclusive evidence.
Where this research is happening
Durham, United States
- Duke University — Durham, United States (Active)
Researchers
- Principal investigator: Chakraborty, Hrishikesh — Duke University
- Study coordinator: Chakraborty, Hrishikesh
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.