Spironolactone for heart failure with preserved ejection fraction (HFpEF)

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-11369457

This project tests whether starting spironolactone helps adults with HFpEF (normal or near-normal heart pumping) live better and avoid hospital stays.

Quick facts

Phase['FUNDING_OTHER']
Study typeNih_funding
SexAll
SponsorDUKE UNIVERSITY (nih funded)
Locations1 site (DURHAM, UNITED STATES)
Trial IDNIH-11369457 on ClinicalTrials.gov

What this research studies

If you have HFpEF, this effort may invite you to join a large, streamlined randomized program where clinics start some people on spironolactone and follow everyone for heart-related hospitalizations and other outcomes. The work is coordinated from Duke University and carried out at multiple participating hospitals and clinics to keep procedures simple and practical. Enrollment draws on a registry-based approach to speed recruitment and reduce extra visits, and the design includes blinded procedures and active follow-up to track events. The goal is to produce clear, usable results about whether spironolactone improves outcomes for people like you.

Who could benefit from this research

Good fit: Adults aged 21 and older with symptomatic heart failure and a preserved (normal or near-normal) left ventricular ejection fraction who receive care at participating sites are the most likely candidates.

Not a fit: People with reduced ejection fraction or those with contraindications to spironolactone (for example severe kidney disease or high potassium) are unlikely to benefit from this intervention or participation.

Why it matters

Potential benefit: If successful, this could reduce heart-failure hospitalizations and improve symptoms or other heart-related outcomes for people with HFpEF.

How similar studies have performed: A prior large trial (TOPCAT) gave mixed results—no overall benefit on the primary composite endpoint but a reduction in heart-failure hospitalizations in analyses limited to the Americas—so the approach is promising but not yet settled.

Where this research is happening

DURHAM, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.