Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (NCT02901184)
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT-HFPEF
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Advanced Cardiovascular LLC — Alexander City, Alabama
Age range: 50 Years to 99 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (78 Sites)
Showing the first 25 of 78 sites.
- Advanced Cardiovascular LLC — Alexander City, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama
- Banner - University Medical Group — Tucson, Arizona
- MedStar Cardiovascular Research Network — Washington D.C., District of Columbia
- Howard University Hospital — Washington D.C., District of Columbia
- Holy Cross Hospital — Fort Lauderdale, Florida
- Piedmont Atlanta Hospital — Atlanta, Georgia
- Wellstar Health System, Inc. — Marietta, Georgia
- Queens Medical Center — Honolulu, Hawaii
- Fox Valley Clinical Research Center, LLC — Aurora, Illinois
- University of Illinois at Chicago — Chicago, Illinois
- Alexian Brothers Medical Center — Elk Grove Village, Illinois
- Methodist Medical Center of Illinois — Peoria, Illinois
- St. Vincent Medical Group — Indianapolis, Indiana
- Ochsner Medical Center — New Orleans, Louisiana
- Shady Grove Adventist Hospital — Rockville, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Pentucket Medical Associates — Haverhill, Massachusetts
- Charles River Medical Associates — Natick, Massachusetts
- Newton-Wellesley Hospital — Newton, Massachusetts
- University of Michigan Medical Center — Ann Arbor, Michigan
- Ascension Genesys Hospital — Grand Blanc, Michigan
- The Heart House Haddon Heights — Haddon Heights, New Jersey
- Rutgers University - Robert Wood Johnson Medical School — New Brunswick, New Jersey
- University of New Mexico Health Science Center — Albuquerque, New Mexico
📞 Contact the Study Coordinator
Phone: +46186110181
Email: anna.gustavsson@ucr.uu.se
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure With Preserved Ejection Fraction
- Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients — Baltimore, Maryland
- Cardiac Rehab Effects in HFpEF — Salt Lake City, Utah
- Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction — Naples, Florida
- IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency — Durham, North Carolina
- Matching Perfusion and Metabolic Activity in HFpEF — Philadelphia, Pennsylvania
- Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction — Kelowna, British Columbia
Explore by condition: All Heart Failure With Preserved Ejection Fraction clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.