Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Start Date
11/23/2017
Completion Date
12/1/2026
Summary
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.
Eligibility Criteria
Age Range: 50 years to 99 years
Interventions
Spironolactone
Standard care
Conditions
Locations
Advanced Cardiovascular LLC
Alexander City, Alabama 35010
United States
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Banner - University Medical Group
Tucson, Arizona 85724
United States
MedStar Cardiovascular Research Network
Washington D.C., District of Columbia 20010
United States
Howard University Hospital
Washington D.C., District of Columbia 20060
United States
Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
Piedmont Atlanta Hospital
Atlanta, Georgia 30309
United States
Wellstar Health System, Inc.
Marietta, Georgia 30060
United States
Queens Medical Center
Honolulu, Hawaii 96813
United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois 60506-1400
United States
University of Illinois at Chicago
Chicago, Illinois 60612
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois 60007
United States
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United States
St. Vincent Medical Group
Indianapolis, Indiana 46260
United States
Ochsner Medical Center
New Orleans, Louisiana 85724
United States
Shady Grove Adventist Hospital
Rockville, Maryland 20850
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Pentucket Medical Associates
Haverhill, Massachusetts 01830
United States
Charles River Medical Associates
Natick, Massachusetts 01760
United States
Newton-Wellesley Hospital
Newton, Massachusetts 02462
United States
University of Michigan Medical Center
Ann Arbor, Michigan 48109
United States
Ascension Genesys Hospital
Grand Blanc, Michigan 48439
United States
The Heart House Haddon Heights
Haddon Heights, New Jersey 08035
United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United States
University of New Mexico Health Science Center
Albuquerque, New Mexico 87131
United States
University at Buffalo
Buffalo, New York 14203
United States
Northwell Health - Manhasset
Manhasset, New York 11030
United States
Mount Sinai Medical Cente
New York, New York 10029
United States
Mid Carolina Cardiology Research
Charlotte, North Carolina 28204
United States
Duke University
Durham, North Carolina 27710-4000
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267-0542
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Stern Cardiovascular Center
Germantown, Tennessee 38138
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
University of Miami Hospital
Miami, Texas 33136
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Angereds närsjukhus
Angered,
Sweden
Hälsostaden Ängelholms sjukhus
Ängelholm,
Sweden
Falu lasarett
Falun,
Sweden
Närsjukvården i Finspång
Finspång,
Sweden
Vårdcentralen Centrum i Flen
Flen,
Sweden
Sahgrenska University Hospital Östra
Gothenburg,
Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg,
Sweden
Hemse Vårdcentral
Hemse,
Sweden
Karolinska University Hospital
Huddinge,
Sweden
Länssjukhuset Ryhov
Jönköping, 55185
Sweden
Blekingesjukhuset
Karlskrona, 37185
Sweden
Hjärtmottagningen, Centralsjukhuset
Karlstad, 65230
Sweden
Västmanlands sjukhus Köping
Köping,
Sweden
Centralsjukhuset Kristianstad
Kristianstad,
Sweden
Lasarettet i Landskrona
Landskrona,
Sweden
Skaraborgs sjukhus i Lidköping
Lidköping,
Sweden
Linköpings Universitetssjukhus
Linköping, 58185
Sweden
VO Akut- och internmedicin, Skånes Universitetssjukhus
Lund, 22185
Sweden
Capio Citykliniken
Lund,
Sweden
FO Kranskärl/Svikt, Skånes Universitetssjukhus
Lund,
Sweden
Hjärtavdelningen, Skånes Universitetssjukhus
Malmö, 20502
Sweden
Kliniska forskningsenheten Skånes Universitetssjukhus
Malmö,
Sweden
Mariefreds Vårdcentral
Mariefred,
Sweden
Sahlgrenska University Hospital Mölndal
Mölndal,
Sweden
Kardiologikliniken, Vrinnevisjukhuset
Norrköping, 60182
Sweden
Oskarshamns sjukhus
Oskarshamn,
Sweden
Örebro University Hospital
Örebro,
Sweden
Skellefteå lasarett
Skellefteå,
Sweden
Karolinska University Hospital
Solna,
Sweden
Södertälje sjukhus
Södertälje,
Sweden
VO Kardiologi, Södersjukhuset AB
Stockholm, 11883
Sweden
Capio S:t Görans sjukhus AB
Stockholm,
Sweden
Danderyds sjukhus AB
Stockholm,
Sweden
Länssjukhuset Sundsvall-Härnösand
Sundsvall,
Sweden
Sundsvalls Vårdcentral
Sundsvall,
Sweden
Uppsala University Hospital, Cardiology dept
Uppsala,
Sweden
Uppsala University Hospital, Internal Medicine dept
Uppsala,
Sweden
Medicinkliniken, Hallands sjukhus
Varberg, 43281
Sweden
Västmanlands sjukhus Västerås
Västerås,
Sweden
Västerviks sjukhus
Västervik,
Sweden