Actively Recruiting
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Led by Uppsala University · Updated on 2024-10-22
2000
Participants Needed
78
Research Sites
470 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
K
Karolinska University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 50 years or older
- Stable heart failure defined by symptoms and signs as judged by local Investigator
- Left ventricular ejection fraction 40% or higher recorded in the last 12 months
- Elevated natriuretic peptide levels as defined by specific NT-proBNP or BNP values
- Regular use of loop diuretics daily or most days of the week
- New York Heart Association (NYHA) Class II-IV heart failure symptoms
You will not qualify if you...
- Previously enrolled in this study
- Known ejection fraction less than 40% ever
- Current absolute indication or contraindication for mineral receptor antagonist treatment
- Known chronic liver disease
- Known primary cardiomyopathy or primary hemodynamically significant valve disease
- Right-sided heart failure not due to left-sided heart failure
- Significant chronic pulmonary disease or requirement for home oxygen
- Symptomatic anemia with hemoglobin less than 10 g/dL
- Heart transplant or left ventricular assist device recipient
- Presence of cardiac resynchronization therapy device
- Systolic blood pressure less than 90 or greater than 160 mmHg
- Potassium level greater than 5.0 mmol/L
- Estimated glomerular filtration rate less than 30 ml/min/1.73m2 or creatinine greater than 2.5 mg/dL
- Current lithium use
- Current dialysis
- Actual or potential for pregnancy
- Participation in another trial studying mineralocorticoid receptor antagonists
- Any condition that may interfere with adherence to the trial protocol
AI-Screening
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Trial Site Locations
Total: 78 locations
1
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
Terminated
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Terminated
3
Banner - University Medical Group
Tucson, Arizona, United States, 85724
Terminated
4
MedStar Cardiovascular Research Network
Washington D.C., District of Columbia, United States, 20010
Terminated
5
Howard University Hospital
Washington D.C., District of Columbia, United States, 20060
Terminated
6
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Terminated
7
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Terminated
8
Wellstar Health System, Inc.
Marietta, Georgia, United States, 30060
Terminated
9
Queens Medical Center
Honolulu, Hawaii, United States, 96813
Terminated
10
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States, 60506-1400
Terminated
11
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Terminated
12
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Terminated
13
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Terminated
14
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46260
Terminated
15
Ochsner Medical Center
New Orleans, Louisiana, United States, 85724
Terminated
16
Shady Grove Adventist Hospital
Rockville, Maryland, United States, 20850
Terminated
17
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Terminated
18
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
Terminated
19
Charles River Medical Associates
Natick, Massachusetts, United States, 01760
Terminated
20
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Terminated
21
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Terminated
22
Ascension Genesys Hospital
Grand Blanc, Michigan, United States, 48439
Terminated
23
The Heart House Haddon Heights
Haddon Heights, New Jersey, United States, 08035
Terminated
24
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Terminated
25
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
Terminated
26
University at Buffalo
Buffalo, New York, United States, 14203
Terminated
27
Northwell Health - Manhasset
Manhasset, New York, United States, 11030
Terminated
28
Mount Sinai Medical Cente
New York, New York, United States, 10029
Terminated
29
Mid Carolina Cardiology Research
Charlotte, North Carolina, United States, 28204
Terminated
30
Duke University
Durham, North Carolina, United States, 27710-4000
Terminated
31
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0542
Terminated
32
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Terminated
33
Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Terminated
34
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Terminated
35
Stern Cardiovascular Center
Germantown, Tennessee, United States, 38138
Terminated
36
Baylor University Medical Center
Dallas, Texas, United States, 75246
Terminated
37
University of Miami Hospital
Miami, Texas, United States, 33136
Terminated
38
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Terminated
39
Angereds närsjukhus
Angered, Sweden
Terminated
40
Hälsostaden Ängelholms sjukhus
Ängelholm, Sweden
Terminated
41
Falu lasarett
Falun, Sweden
Actively Recruiting
42
Närsjukvården i Finspång
Finspång, Sweden
Terminated
43
Vårdcentralen Centrum i Flen
Flen, Sweden
Actively Recruiting
44
Sahgrenska University Hospital Östra
Gothenburg, Sweden
Actively Recruiting
45
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Actively Recruiting
46
Hemse Vårdcentral
Hemse, Sweden
Actively Recruiting
47
Karolinska University Hospital
Huddinge, Sweden
Actively Recruiting
48
Länssjukhuset Ryhov
Jönköping, Sweden, 55185
Actively Recruiting
49
Blekingesjukhuset
Karlskrona, Sweden, 37185
Active, Not Recruiting
50
Hjärtmottagningen, Centralsjukhuset
Karlstad, Sweden, 65230
Actively Recruiting
51
Västmanlands sjukhus Köping
Köping, Sweden
Actively Recruiting
52
Centralsjukhuset Kristianstad
Kristianstad, Sweden
Terminated
53
Lasarettet i Landskrona
Landskrona, Sweden
Actively Recruiting
54
Skaraborgs sjukhus i Lidköping
Lidköping, Sweden
Actively Recruiting
55
Linköpings Universitetssjukhus
Linköping, Sweden, 58185
Actively Recruiting
56
VO Akut- och internmedicin, Skånes Universitetssjukhus
Lund, Sweden, 22185
Terminated
57
Capio Citykliniken
Lund, Sweden
Actively Recruiting
58
FO Kranskärl/Svikt, Skånes Universitetssjukhus
Lund, Sweden
Actively Recruiting
59
Hjärtavdelningen, Skånes Universitetssjukhus
Malmö, Sweden, 20502
Terminated
60
Kliniska forskningsenheten Skånes Universitetssjukhus
Malmö, Sweden
Actively Recruiting
61
Mariefreds Vårdcentral
Mariefred, Sweden
Actively Recruiting
62
Sahlgrenska University Hospital Mölndal
Mölndal, Sweden
Actively Recruiting
63
Kardiologikliniken, Vrinnevisjukhuset
Norrköping, Sweden, 60182
Actively Recruiting
64
Oskarshamns sjukhus
Oskarshamn, Sweden
Active, Not Recruiting
65
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
66
Skellefteå lasarett
Skellefteå, Sweden
Actively Recruiting
67
Karolinska University Hospital
Solna, Sweden
Actively Recruiting
68
Södertälje sjukhus
Södertälje, Sweden
Terminated
69
VO Kardiologi, Södersjukhuset AB
Stockholm, Sweden, 11883
Actively Recruiting
70
Capio S:t Görans sjukhus AB
Stockholm, Sweden
Actively Recruiting
71
Danderyds sjukhus AB
Stockholm, Sweden
Actively Recruiting
72
Länssjukhuset Sundsvall-Härnösand
Sundsvall, Sweden
Actively Recruiting
73
Sundsvalls Vårdcentral
Sundsvall, Sweden
Terminated
74
Uppsala University Hospital, Cardiology dept
Uppsala, Sweden
Actively Recruiting
75
Uppsala University Hospital, Internal Medicine dept
Uppsala, Sweden
Actively Recruiting
76
Medicinkliniken, Hallands sjukhus
Varberg, Sweden, 43281
Actively Recruiting
77
Västmanlands sjukhus Västerås
Västerås, Sweden
Actively Recruiting
78
Västerviks sjukhus
Västervik, Sweden
Active, Not Recruiting
Research Team
A
Anna Gustavsson (SWE)
CONTACT
W
Will Simmons (US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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