Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
NCT ID: NCT02901184
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2000 participants
INTERVENTIONAL
2017-11-23
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Spironolactone treatment
Spironolactone will be prescribed by the Investigator and filled by patient at conventional pharmacies as 25 mg tablets. The treatment will be on top of standard care. Initial dose is 25 mg/day, which will be increased to target dose 50 mg/day if tolerated. Eplerenone can be prescribed if spironolactone is not tolerated.
Spironolactone
Treatment with Spironolactone tablets on top of standard care
Standard care alone
Patients in the control arm will get the standard care alone
Standard care
Standard care does not involve Spironolactone
Interventions
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Spironolactone
Treatment with Spironolactone tablets on top of standard care
Standard care
Standard care does not involve Spironolactone
Eligibility Criteria
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Inclusion Criteria
* Age ≥50 years
* Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
* Left ventricular ejection fraction (LVEF) ≥40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or ≥50% group)
* Elevated natriuretic peptide levels, as defined by any of the following:
1. most recent NT-proBNP \>300 ng/L (or BNP\>100 pg/mL) in sinus rhythm at time of blood sampling; adjustments may be made for BMI according to table 3.
2. most recent NT-proBNP \>750 ng/L (or BNP \>250 pg/mL) in atrial fibrillation at time of blood sampling; adjustments may be made for BMI according to table 3.
3. NT-proBNP \>1200 ng/L (or BNP \>400 pg/mL) within the last 12 months even if most recent value is lower.
* Regular use of loop diuretics, defined as daily or most days of the week
* NYHA Class II-IV
Exclusion Criteria
* Known Ejection Fraction \< 40% ever
* Current absolute indication or contraindication for MRA (mineral receptor antagonist) in judgement of Investigator
* Known chronic liver disease
* Probable alternative explanations for symptoms:
* Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)
* Primary hemodynamically significant valve disease
* Right-sided HF not due to left-sided HF
* Significant chronic pulmonary disease defined by Investigator or by requirement for home O2
* Symptomatic anemia, defined as Hemoglobin \< 10 g/dL (100 g/L )
* Heart transplant or LVAD (left ventricular assist device) recipient
* Presence of cardiac resynchronization therapy (CRT) device
* Systolic blood pressure \<90 or \>160 mmHg
* K (potassium) \>5.0 mmol/L
* eGFR (estimated glomerular filtration rate) by MDRD (Modification of Diet in Renal Disease) \< 30 ml/min/1.73m2 or creatinine \> 2.5 mg/dL (221 µmol/L )
* Current lithium use
* Current dialysis
* Actual or potential for pregnancy
* Participation in another interventional clinical trial where a mineralocorticoid receptor antagonist is studied
* Any condition that in the opinion of the Investigator may interfere with adherence to trial protocol
50 Years
99 Years
ALL
No
Sponsors
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Karolinska University
OTHER
Duke Clinical Research Institute
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Lars H Lund, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Bertram Pitt
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Advanced Cardiovascular LLC
Alexander City, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner - University Medical Group
Tucson, Arizona, United States
MedStar Cardiovascular Research Network
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Wellstar Health System, Inc.
Marietta, Georgia, United States
Queens Medical Center
Honolulu, Hawaii, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Shady Grove Adventist Hospital
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Pentucket Medical Associates
Haverhill, Massachusetts, United States
Charles River Medical Associates
Natick, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Ascension Genesys Hospital
Grand Blanc, Michigan, United States
The Heart House Haddon Heights
Haddon Heights, New Jersey, United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
University at Buffalo
Buffalo, New York, United States
Northwell Health - Manhasset
Manhasset, New York, United States
Mount Sinai Medical Cente
New York, New York, United States
Mid Carolina Cardiology Research
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Stern Cardiovascular Center
Germantown, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Miami Hospital
Miami, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 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, , Sweden
Blekingesjukhuset
Karlskrona, , Sweden
Hjärtmottagningen, Centralsjukhuset
Karlstad, , Sweden
Västmanlands sjukhus Köping
Köping, , Sweden
Centralsjukhuset Kristianstad
Kristianstad, , Sweden
Lasarettet i Landskrona
Landskrona, , Sweden
Skaraborgs sjukhus i Lidköping
Lidköping, , Sweden
Linköpings Universitetssjukhus
Linköping, , Sweden
VO Akut- och internmedicin, Skånes Universitetssjukhus
Lund, , Sweden
Capio Citykliniken
Lund, , Sweden
FO Kranskärl/Svikt, Skånes Universitetssjukhus
Lund, , Sweden
Hjärtavdelningen, Skånes Universitetssjukhus
Malmo, , Sweden
Kliniska forskningsenheten Skånes Universitetssjukhus
Malmo, , Sweden
Mariefreds Vårdcentral
Mariefred, , Sweden
Sahlgrenska University Hospital Mölndal
Mölndal, , Sweden
Kardiologikliniken, Vrinnevisjukhuset
Norrköping, , 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, , 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, , Sweden
Västmanlands sjukhus Västerås
Västerås, , Sweden
Västerviks sjukhus
Västervik, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Fahed Sulaiman
Role: primary
Kaj Possler
Role: primary
Mikael Fu
Role: primary
Charlotta Ljungman
Role: primary
Ann Hovland-Tånneryd
Role: primary
Lars H Lund
Role: primary
Patric Karlström
Role: primary
Edit Floderer
Role: primary
Emöke Fodor
Role: primary
Fredrik Kymle
Role: primary
Magnus Peterson
Role: primary
Henriette van der Wal
Role: primary
Carl-Johan Lindholm
Role: primary
Grunde Gjesdal
Role: primary
Tobias Reitberger
Role: primary
Pär Parén
Role: primary
Dimitros Ftakas
Role: primary
Barna Szabó
Role: primary
Lars Gustafsson
Role: primary
Lars H Lund
Role: primary
Carin Corovic Cabrera
Role: primary
Majid Jourak
Role: primary
Jonas Spaak
Role: primary
Mohammad Kavianipour
Role: primary
Tymon Pol, MD, Phd
Role: primary
Michael Dimberg
Role: primary
Petru Tutuainu
Role: primary
Ingmar Lönnberg
Role: primary
Other Identifiers
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