Independent directory Public ClinicalTrials.gov records United States
Clinical Trials Finder
Objective public record navigation
ClinicalTrials.gov record
Recruiting Phase 3 Interventional

Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

ClinicalTrials.gov ID: NCT02901184

Public ClinicalTrials.gov record NCT02901184. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search
ClinicalTrials.gov public records Last synced Sep 12, 2026, 4:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT-HFPEF

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02901184
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Uppsala University
Other
Enrollment
2,000 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
50 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 22, 2017
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026
Last update posted
Oct 21, 2024

2017 – 2026

United States locations

U.S. sites
38
U.S. states
20
U.S. cities
37
Facility City State ZIP Site status
Advanced Cardiovascular LLC Alexander City Alabama 35010 Terminated
University of Alabama at Birmingham Birmingham Alabama 35294 Terminated
Banner - University Medical Group Tucson Arizona 85724 Terminated
MedStar Cardiovascular Research Network Washington D.C. District of Columbia 20010 Terminated
Howard University Hospital Washington D.C. District of Columbia 20060 Terminated
Holy Cross Hospital Fort Lauderdale Florida 33308 Terminated
Piedmont Atlanta Hospital Atlanta Georgia 30309 Terminated
Wellstar Health System, Inc. Marietta Georgia 30060 Terminated
Queens Medical Center Honolulu Hawaii 96813 Terminated
Fox Valley Clinical Research Center, LLC Aurora Illinois 60506-1400 Terminated
University of Illinois at Chicago Chicago Illinois 60612 Terminated
Alexian Brothers Medical Center Elk Grove Village Illinois 60007 Terminated
Methodist Medical Center of Illinois Peoria Illinois 61636 Terminated
St. Vincent Medical Group Indianapolis Indiana 46260 Terminated
Ochsner Medical Center New Orleans Louisiana 85724 Terminated
Shady Grove Adventist Hospital Rockville Maryland 20850 Terminated
Brigham and Women's Hospital Boston Massachusetts 02115 Terminated
Pentucket Medical Associates Haverhill Massachusetts 01830 Terminated
Charles River Medical Associates Natick Massachusetts 01760 Terminated
Newton-Wellesley Hospital Newton Massachusetts 02462 Terminated
University of Michigan Medical Center Ann Arbor Michigan 48109 Terminated
Ascension Genesys Hospital Grand Blanc Michigan 48439 Terminated
The Heart House Haddon Heights Haddon Heights New Jersey 08035 Terminated
Rutgers University - Robert Wood Johnson Medical School New Brunswick New Jersey 08901 Terminated
University of New Mexico Health Science Center Albuquerque New Mexico 87131 Terminated
University at Buffalo Buffalo New York 14203 Terminated
Northwell Health - Manhasset Manhasset New York 11030 Terminated
Mount Sinai Medical Cente New York New York 10029 Terminated
Mid Carolina Cardiology Research Charlotte North Carolina 28204 Terminated
Duke University Durham North Carolina 27710-4000 Terminated
University of Cincinnati Medical Center Cincinnati Ohio 45267-0542 Terminated
Penn State Milton S Hershey Medical Center Hershey Pennsylvania 17033 Terminated
Jefferson University Hospital Philadelphia Pennsylvania 19107 Terminated
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213 Terminated
Stern Cardiovascular Center Germantown Tennessee 38138 Terminated
Baylor University Medical Center Dallas Texas 75246 Terminated
University of Miami Hospital Miami Texas 33136 Terminated
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 Terminated

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02901184, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2024 · Synced Sep 12, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02901184 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →