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

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Spironolactone
Standard care
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    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:

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

Sites / Locations

  • Advanced Cardiovascular LLCRecruiting
  • University of Alabama at Birmingham
  • Banner - University Medical GroupRecruiting
  • MedStar Cardiovascular Research NetworkRecruiting
  • Howard University Hospital
  • Holy Cross HospitalRecruiting
  • Piedmont Atlanta HospitalRecruiting
  • Wellstar Health System, Inc.Recruiting
  • Queens Medical Center
  • Fox Valley Clinical Research Center, LLCRecruiting
  • University of Illinois at ChicagoRecruiting
  • Alexian Brothers Medical Center
  • Methodist Medical Center of Illinois
  • St. Vincent Medical GroupRecruiting
  • Ochsner Medical CenterRecruiting
  • Shady Grove Adventist HospitalRecruiting
  • Brigham and Women's Hospital
  • Pentucket Medical AssociatesRecruiting
  • Charles River Medical Associates
  • Newton-Wellesley HospitalRecruiting
  • University of Michigan Medical CenterRecruiting
  • Ascension Genesys Hospital
  • The Heart House Haddon Heights
  • Rutgers University - Robert Wood Johnson Medical SchoolRecruiting
  • University of New Mexico Health Science CenterRecruiting
  • University at Buffalo
  • Northwell Health - ManhassetRecruiting
  • Mount Sinai Medical CenteRecruiting
  • Mid Carolina Cardiology ResearchRecruiting
  • Duke UniversityRecruiting
  • University of Cincinnati Medical Center
  • Penn State Milton S Hershey Medical CenterRecruiting
  • Jefferson University HospitalRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Stern Cardiovascular CenterRecruiting
  • Baylor University Medical CenterRecruiting
  • University of Miami Hospital
  • University of Texas Health Science Center at San AntonioRecruiting
  • Angereds närsjukhus
  • Falu lasarettRecruiting
  • Närsjukvården i Finspång
  • Vårdcentralen Centrum i FlenRecruiting
  • Sahgrenska University Hospital ÖstraRecruiting
  • Sahlgrenska UniversitetssjukhusetRecruiting
  • Hemse VårdcentralRecruiting
  • Karolinska University HospitalRecruiting
  • Länssjukhuset RyhovRecruiting
  • Blekingesjukhuset
  • Hjärtmottagningen, CentralsjukhusetRecruiting
  • Centralsjukhuset Kristianstad
  • Västmanlands sjukhus KöpingRecruiting
  • Lasarettet i LandskronaRecruiting
  • Skaraborgs sjukhus i LidköpingRecruiting
  • Linköpings UniversitetssjukhusRecruiting
  • VO Akut- och internmedicin, Skånes Universitetssjukhus
  • Capio CityklinikenRecruiting
  • FO Kranskärl/Svikt, Skånes UniversitetssjukhusRecruiting
  • Hjärtavdelningen, Skånes Universitetssjukhus
  • Kliniska forskningsenheten Skånes UniversitetssjukhusRecruiting
  • Mariefreds VårdcentralRecruiting
  • Sahlgrenska University Hospital MölndalRecruiting
  • Kardiologikliniken, VrinnevisjukhusetRecruiting
  • Oskarshamns sjukhus
  • Skellefteå lasarettRecruiting
  • Karolinska University HospitalRecruiting
  • VO Kardiologi, Södersjukhuset ABRecruiting
  • Capio S:t Görans sjukhus ABRecruiting
  • Danderyds sjukhus ABRecruiting
  • Länssjukhuset Sundsvall-HärnösandRecruiting
  • Sundsvalls Vårdcentral
  • Södertälje sjukhus
  • Uppsala University Hospital, Cardiology deptRecruiting
  • Uppsala University Hospital, Internal Medicine deptRecruiting
  • Medicinkliniken, Hallands sjukhusRecruiting
  • Västerviks sjukhus
  • Västmanlands sjukhus VästeråsRecruiting
  • Hälsostaden Ängelholms sjukhus
  • Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Spironolactone treatment

Standard care alone

Arm Description

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.

Patients in the control arm will get the standard care alone

Outcomes

Primary Outcome Measures

Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry US: Collected in eCRF or via call center interview

Secondary Outcome Measures

Time to CV Death or first HF hospitalization
Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview
Time to CV Death
Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview
Incidence rate for total HF hospitalizations
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time to HF hospitalizations
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time to all-cause mortality
Sweden: Information on Death from the Swedish Causes of death registry. US: Collected in eCRF or via call center interview
Incidence rate for all-cause hospitalizations
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time to all-cause hospitalizations
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Incidence rate for all-cause hospitalizations or all-cause mortality
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview

Full Information

First Posted
September 9, 2016
Last Updated
June 13, 2023
Sponsor
Uppsala University
Collaborators
Karolinska University, Duke Clinical Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02901184
Brief Title
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Acronym
SPIRRIT
Official Title
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT-HFPEF
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Karolinska University, Duke Clinical Research Institute, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard care alone
Arm Type
Placebo Comparator
Arm Description
Patients in the control arm will get the standard care alone
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Treatment with Spironolactone tablets on top of standard care
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care does not involve Spironolactone
Primary Outcome Measure Information:
Title
Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
Description
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Secondary Outcome Measure Information:
Title
Time to CV Death or first HF hospitalization
Description
Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Time to CV Death
Description
Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Incidence rate for total HF hospitalizations
Description
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Time to HF hospitalizations
Description
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Time to all-cause mortality
Description
Sweden: Information on Death from the Swedish Causes of death registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start
Title
Incidence rate for all-cause hospitalizations
Description
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Time to all-cause hospitalizations
Description
Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)
Title
Incidence rate for all-cause hospitalizations or all-cause mortality
Description
Sweden: Information on Death from the Swedish Causes of death registry and information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
Time Frame
Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Gustavsson (SWE)
Phone
+46186110181
Email
anna.gustavsson@ucr.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Will Simmons (US)
Phone
919-668-0541
Email
will.simmons@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars H Lund, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertram Pitt
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Cardiovascular LLC
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Banner - University Medical Group
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Cardiovascular Research Network
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellstar Health System, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506-1400
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
St. Vincent Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
Shady Grove Adventist Hospital
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Pentucket Medical Associates
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Individual Site Status
Recruiting
Facility Name
Charles River Medical Associates
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Genesys Hospital
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Heart House Haddon Heights
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rutgers University - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwell Health - Manhasset
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Cente
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Carolina Cardiology Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0542
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Stern Cardiovascular Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital
City
Miami
State/Province
Texas
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Angereds närsjukhus
City
Angered
Country
Sweden
Individual Site Status
Terminated
Facility Name
Falu lasarett
City
Falun
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahed Sulaiman
Facility Name
Närsjukvården i Finspång
City
Finspång
Country
Sweden
Individual Site Status
Terminated
Facility Name
Vårdcentralen Centrum i Flen
City
Flen
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaj Possler
Facility Name
Sahgrenska University Hospital Östra
City
Göteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Fu
First Name & Middle Initial & Last Name & Degree
Mikael Fu
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotta Ljungman
Facility Name
Hemse Vårdcentral
City
Hemse
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Hovland-Tånneryd
Facility Name
Karolinska University Hospital
City
Huddinge
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars H Lund
First Name & Middle Initial & Last Name & Degree
Lars H Lund
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patric Karlström
Facility Name
Blekingesjukhuset
City
Karlskrona
ZIP/Postal Code
37185
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Hjärtmottagningen, Centralsjukhuset
City
Karlstad
ZIP/Postal Code
65230
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edit Floderer
Facility Name
Centralsjukhuset Kristianstad
City
Kristianstad
Country
Sweden
Individual Site Status
Terminated
Facility Name
Västmanlands sjukhus Köping
City
Köping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jalal Amin
First Name & Middle Initial & Last Name & Degree
Jalal Amin
Facility Name
Lasarettet i Landskrona
City
Landskrona
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Kymle
Facility Name
Skaraborgs sjukhus i Lidköping
City
Lidköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnus Peterson
Facility Name
Linköpings Universitetssjukhus
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henriette van der Wal
Facility Name
VO Akut- och internmedicin, Skånes Universitetssjukhus
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Terminated
Facility Name
Capio Citykliniken
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl-Johan Lindholm
Facility Name
FO Kranskärl/Svikt, Skånes Universitetssjukhus
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grunde Gjesdal
Facility Name
Hjärtavdelningen, Skånes Universitetssjukhus
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Individual Site Status
Terminated
Facility Name
Kliniska forskningsenheten Skånes Universitetssjukhus
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Svenson
Facility Name
Mariefreds Vårdcentral
City
Mariefred
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Reitberger
First Name & Middle Initial & Last Name & Degree
Tobias Reitberger
Facility Name
Sahlgrenska University Hospital Mölndal
City
Mölndal
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pär Parén
First Name & Middle Initial & Last Name & Degree
Pär Parén
Facility Name
Kardiologikliniken, Vrinnevisjukhuset
City
Norrköping
ZIP/Postal Code
60182
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitros Ftakas
Facility Name
Oskarshamns sjukhus
City
Oskarshamn
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Skellefteå lasarett
City
Skellefteå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Gustafsson
Facility Name
Karolinska University Hospital
City
Solna
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars H Lund
First Name & Middle Initial & Last Name & Degree
Lars H Lund
Facility Name
VO Kardiologi, Södersjukhuset AB
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin Corovic Cabrera
Facility Name
Capio S:t Görans sjukhus AB
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika Löfström
First Name & Middle Initial & Last Name & Degree
Ulrika Löfström
Facility Name
Danderyds sjukhus AB
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Persson
Facility Name
Länssjukhuset Sundsvall-Härnösand
City
Sundsvall
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Kavianipour
Facility Name
Sundsvalls Vårdcentral
City
Sundsvall
Country
Sweden
Individual Site Status
Terminated
Facility Name
Södertälje sjukhus
City
Södertälje
Country
Sweden
Individual Site Status
Terminated
Facility Name
Uppsala University Hospital, Cardiology dept
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Christersson, MD, Phd
First Name & Middle Initial & Last Name & Degree
Christina Christersson, MD, PhD
Facility Name
Uppsala University Hospital, Internal Medicine dept
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Dimberg
Facility Name
Medicinkliniken, Hallands sjukhus
City
Varberg
ZIP/Postal Code
43281
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petru Tutuainu
Facility Name
Västerviks sjukhus
City
Västervik
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Västmanlands sjukhus Västerås
City
Västerås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingmar Lönnberg
First Name & Middle Initial & Last Name & Degree
Ingmar Lönnberg
Facility Name
Hälsostaden Ängelholms sjukhus
City
Ängelholm
Country
Sweden
Individual Site Status
Terminated
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barna Szabó
First Name & Middle Initial & Last Name & Degree
Barna Szabó

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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