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

Who is this study for? Patients with Heart Failure with Preserved Ejection Fraction
What treatments are being studied? Spironolactone
Status: Recruiting
Location: See all (78) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Advanced Cardiovascular LLC
TERMINATED
Alexander City
University of Alabama at Birmingham
TERMINATED
Birmingham
Arizona
Banner - University Medical Group
TERMINATED
Tucson
Washington, D.c.
Howard University Hospital
TERMINATED
Washington D.c.
MedStar Cardiovascular Research Network
TERMINATED
Washington D.c.
Florida
Holy Cross Hospital
TERMINATED
Fort Lauderdale
Georgia
Piedmont Atlanta Hospital
TERMINATED
Atlanta
Wellstar Health System, Inc.
TERMINATED
Marietta
Hawaii
Queens Medical Center
TERMINATED
Honolulu
Illinois
Fox Valley Clinical Research Center, LLC
TERMINATED
Aurora
University of Illinois at Chicago
TERMINATED
Chicago
Alexian Brothers Medical Center
TERMINATED
Elk Grove Village
Methodist Medical Center of Illinois
TERMINATED
Peoria
Indiana
St. Vincent Medical Group
TERMINATED
Indianapolis
Louisiana
Ochsner Medical Center
TERMINATED
New Orleans
Massachusetts
Brigham and Women's Hospital
TERMINATED
Boston
Pentucket Medical Associates
TERMINATED
Haverhill
Charles River Medical Associates
TERMINATED
Natick
Newton-Wellesley Hospital
TERMINATED
Newton
Maryland
Shady Grove Adventist Hospital
TERMINATED
Rockville
Michigan
University of Michigan Medical Center
TERMINATED
Ann Arbor
Ascension Genesys Hospital
TERMINATED
Grand Blanc
North Carolina
Mid Carolina Cardiology Research
TERMINATED
Charlotte
Duke University
TERMINATED
Durham
New Jersey
The Heart House Haddon Heights
TERMINATED
Haddon Heights
Rutgers University - Robert Wood Johnson Medical School
TERMINATED
New Brunswick
New Mexico
University of New Mexico Health Science Center
TERMINATED
Albuquerque
New York
University at Buffalo
TERMINATED
Buffalo
Northwell Health - Manhasset
TERMINATED
Manhasset
Mount Sinai Medical Cente
TERMINATED
New York
Ohio
University of Cincinnati Medical Center
TERMINATED
Cincinnati
Pennsylvania
Penn State Milton S Hershey Medical Center
TERMINATED
Hershey
Jefferson University Hospital
TERMINATED
Philadelphia
University of Pittsburgh Medical Center
TERMINATED
Pittsburgh
Tennessee
Stern Cardiovascular Center
TERMINATED
Germantown
Texas
Baylor University Medical Center
TERMINATED
Dallas
University of Miami Hospital
TERMINATED
Miami
University of Texas Health Science Center at San Antonio
TERMINATED
San Antonio
Other Locations
Sweden
Hälsostaden Ängelholms sjukhus
TERMINATED
Ängelholm
Angereds närsjukhus
TERMINATED
Angered
Falu lasarett
RECRUITING
Falun
Närsjukvården i Finspång
TERMINATED
Finspång
Vårdcentralen Centrum i Flen
RECRUITING
Flen
Sahgrenska University Hospital Östra
RECRUITING
Gothenburg
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Hemse Vårdcentral
RECRUITING
Hemse
Karolinska University Hospital
RECRUITING
Huddinge
Länssjukhuset Ryhov
RECRUITING
Jönköping
Blekingesjukhuset
ACTIVE_NOT_RECRUITING
Karlskrona
Hjärtmottagningen, Centralsjukhuset
RECRUITING
Karlstad
Västmanlands sjukhus Köping
RECRUITING
Köping
Centralsjukhuset Kristianstad
TERMINATED
Kristianstad
Lasarettet i Landskrona
RECRUITING
Landskrona
Skaraborgs sjukhus i Lidköping
RECRUITING
Lidköping
Linköpings Universitetssjukhus
RECRUITING
Linköping
Capio Citykliniken
RECRUITING
Lund
FO Kranskärl/Svikt, Skånes Universitetssjukhus
RECRUITING
Lund
VO Akut- och internmedicin, Skånes Universitetssjukhus
TERMINATED
Lund
Hjärtavdelningen, Skånes Universitetssjukhus
TERMINATED
Malmo
Kliniska forskningsenheten Skånes Universitetssjukhus
RECRUITING
Malmo
Mariefreds Vårdcentral
RECRUITING
Mariefred
Sahlgrenska University Hospital Mölndal
RECRUITING
Mölndal
Kardiologikliniken, Vrinnevisjukhuset
RECRUITING
Norrköping
Örebro University Hospital
RECRUITING
Örebro
Oskarshamns sjukhus
ACTIVE_NOT_RECRUITING
Oskarshamn
Skellefteå lasarett
RECRUITING
Skellefteå
Södertälje sjukhus
TERMINATED
Södertälje
Karolinska University Hospital
RECRUITING
Solna
Capio S:t Görans sjukhus AB
RECRUITING
Stockholm
Danderyds sjukhus AB
RECRUITING
Stockholm
VO Kardiologi, Södersjukhuset AB
RECRUITING
Stockholm
Länssjukhuset Sundsvall-Härnösand
RECRUITING
Sundsvall
Sundsvalls Vårdcentral
TERMINATED
Sundsvall
Uppsala University Hospital, Cardiology dept
RECRUITING
Uppsala
Uppsala University Hospital, Internal Medicine dept
RECRUITING
Uppsala
Medicinkliniken, Hallands sjukhus
RECRUITING
Varberg
Västmanlands sjukhus Västerås
RECRUITING
Västerås
Västerviks sjukhus
ACTIVE_NOT_RECRUITING
Västervik
Contact Information
Primary
Anna Gustavsson (SWE)
anna.gustavsson@ucr.uu.se
+46186110181
Backup
Will Simmons (US)
will.simmons@duke.edu
919-668-0541
Time Frame
Start Date: 2017-11-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 2000
Treatments
Active_comparator: 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.
Placebo_comparator: Standard care alone
Patients in the control arm will get the standard care alone
Sponsors
Collaborators: Karolinska University, Duke Clinical Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Uppsala University

This content was sourced from clinicaltrials.gov