Heart Failure Clinical Trial

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

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 (2550 patients) and HFPEF patients in US (650 patients). 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 3 years and study duration 5 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 632 events the sample size requires 3012 patients conservatively rounded to approximately 3200 patients. A detailed feasibility assessment shows that there will be > 8197 eligible patients to meet the required enrollment of 3200 patients.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Written informed consent
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:

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.
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.
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:

Previously enrolled in this study

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

2000

Study ID:

NCT02901184

Recruitment Status:

Recruiting

Sponsor:

Uppsala University

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There are 46 Locations for this study

See Locations Near You

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 District of Columbia, 20010, United States
Howard University Hospital
Washington 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, 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, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, 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
Falu lasarett
Falun , , Sweden More Info
Fahed Sulaiman
Contact
Närsjukvården i Finspång
Finspång , , Sweden
Vårdcentralen Centrum i Flen
Flen , , Sweden More Info
Kaj Possler
Contact
Sahgrenska University Hospital Östra
Göteborg , , Sweden More Info
Mikael Fu
Contact
Mikael Fu
Principal Investigator
Sahlgrenska Universitetssjukhuset
Göteborg , , Sweden More Info
Charlotta Ljungman
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Hemse Vårdcentral
Hemse , , Sweden More Info
Ann Hovland-Tånneryd
Contact
Karolinska University Hospital
Huddinge , , Sweden More Info
Lars H Lund
Contact
Lars H Lund
Principal Investigator
Länssjukhuset Ryhov
Jönköping , 55185, Sweden More Info
Patric Karlström
Contact
Blekingesjukhuset
Karlskrona , 37185, Sweden
Hjärtmottagningen, Centralsjukhuset
Karlstad , 65230, Sweden More Info
Edit Floderer
Contact
Centralsjukhuset Kristianstad
Kristianstad , , Sweden
Västmanlands sjukhus Köping
Köping , , Sweden More Info
Jalal Amin
Contact
Jalal Amin
Principal Investigator
Lasarettet i Landskrona
Landskrona , , Sweden More Info
Fredrik Kymle
Contact
Skaraborgs sjukhus i Lidköping
Lidköping , , Sweden More Info
Magnus Peterson
Contact
Linköpings Universitetssjukhus
Linköping , 58185, Sweden More Info
Henriette van der Wal
Contact
VO Akut- och internmedicin, Skånes Universitetssjukhus
Lund , 22185, Sweden
Capio Citykliniken
Lund , , Sweden More Info
Carl-Johan Lindholm
Contact
FO Kranskärl/Svikt, Skånes Universitetssjukhus
Lund , , Sweden More Info
Grunde Gjesdal
Contact
Hjärtavdelningen, Skånes Universitetssjukhus
Malmö , 20502, Sweden
Kliniska forskningsenheten Skånes Universitetssjukhus
Malmö , , Sweden More Info
Patrik Svenson
Principal Investigator
Mariefreds Vårdcentral
Mariefred , , Sweden More Info
Tobias Reitberger
Contact
Tobias Reitberger
Principal Investigator
Sahlgrenska University Hospital Mölndal
Mölndal , , Sweden More Info
Pär Parén
Contact
Pär Parén
Principal Investigator
Kardiologikliniken, Vrinnevisjukhuset
Norrköping , 60182, Sweden More Info
Dimitros Ftakas
Contact
Oskarshamns sjukhus
Oskarshamn , , Sweden
Skellefteå lasarett
Skellefteå , , Sweden More Info
Lars Gustafsson
Contact
Karolinska University Hospital
Solna , , Sweden More Info
Lars H Lund
Contact
Lars H Lund
Principal Investigator
VO Kardiologi, Södersjukhuset AB
Stockholm , 11883, Sweden More Info
Carin Corovic Cabrera
Contact
Capio S:t Görans sjukhus AB
Stockholm , , Sweden More Info
Ulrika Löfström
Contact
Ulrika Löfström
Principal Investigator
Danderyds sjukhus AB
Stockholm , , Sweden More Info
Hans Persson
Contact
Länssjukhuset Sundsvall-Härnösand
Sundsvall , , Sweden More Info
Mohammad Kavianipour
Contact
Sundsvalls Vårdcentral
Sundsvall , , Sweden
Södertälje sjukhus
Södertälje , , Sweden
Uppsala University Hospital, Cardiology dept
Uppsala , , Sweden More Info
Christina Christersson, MD, Phd
Contact
Christina Christersson, MD, PhD
Principal Investigator
Uppsala University Hospital, Internal Medicine dept
Uppsala , , Sweden More Info
Michael Dimberg
Contact
Medicinkliniken, Hallands sjukhus
Varberg , 43281, Sweden More Info
Petru Tutuainu
Contact
Västerviks sjukhus
Västervik , , Sweden
Västmanlands sjukhus Västerås
Västerås , , Sweden More Info
Ingmar Lönnberg
Contact
Ingmar Lönnberg
Principal Investigator
Hälsostaden Ängelholms sjukhus
Ängelholm , , Sweden
Örebro University Hospital
Örebro , , Sweden More Info
Barna Szabó
Contact
Barna Szabó
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

2000

Study ID:

NCT02901184

Recruitment Status:

Recruiting

Sponsor:


Uppsala University

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