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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified September 2024 by Uppsala University
Sponsor
Uppsala University
Information Provided by (Responsible Party)
Uppsala University
Clinicaltrials.gov Identifier
NCT02901184
Other Study ID Numbers:
U-2015-030
First Submitted
September 8, 2016
First Posted
September 14, 2016
Last Update Posted
October 21, 2024
Last Verified
September 2024

ClinicalTrials.gov processed this data on October 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Heart Failure With Preserved Ejection Fraction
Drug: SpironolactoneOther: Standard care

Study Design

Study TypeInterventional
Actual Enrollment2000 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleSpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT-HFPEF
Study Start DateNovember 22, 2017
Actual Primary Completion Date6mos 2w from now
Actual Study Completion Date6mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Spironolactone
Treatment with Spironolactone tablets on top of standard care
Standard care alone
Patients in the control arm will get the standard care alone
Other: Standard care
Standard care does not involve Spironolactone

Outcome Measures

Primary Outcome Measures
  1. 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
  1. 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
  2. Time to CV Death
    Sweden: Information on Death from the Swedish Causes of death registry US: Collected in eCRF or via call center interview
  3. 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
  4. Time to HF hospitalizations
    Sweden: Information on information on hospitalization collected from Swedish Patient Registry. US: Collected in eCRF or via call center interview
  5. 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
  6. 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
  7. 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
  8. 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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUppsala University
Locations
Advanced Cardiovascular LLC | Alexander City Alabama, United States, 35010University of Alabama at Birmingham | Birmingham Alabama, United States, 35294Banner - University Medical Group | Tucson Arizona, United States, 85724MedStar Cardiovascular Research Network | Washington D.C. District of Columbia, United States, 20010Howard University Hospital | Washington D.C. District of Columbia, United States, 20060Holy Cross Hospital | Fort Lauderdale Florida, United States, 33308Piedmont Atlanta Hospital | Atlanta Georgia, United States, 30309Wellstar Health System, Inc. | Marietta Georgia, United States, 30060Queens Medical Center | Honolulu Hawaii, United States, 96813Fox Valley Clinical Research Center, LLC | Aurora Illinois, United States, 60506-1400University of Illinois at Chicago | Chicago Illinois, United States, 60612Alexian Brothers Medical Center | Elk Grove Village Illinois, United States, 60007Methodist Medical Center of Illinois | Peoria Illinois, United States, 61636St. Vincent Medical Group | Indianapolis Indiana, United States, 46260Ochsner Medical Center | New Orleans Louisiana, United States, 85724Shady Grove Adventist Hospital | Rockville Maryland, United States, 20850Brigham and Women's Hospital | Boston Massachusetts, United States, 02115Pentucket Medical Associates | Haverhill Massachusetts, United States, 01830Charles River Medical Associates | Natick Massachusetts, United States, 01760Newton-Wellesley Hospital | Newton Massachusetts, United States, 02462University of Michigan Medical Center | Ann Arbor Michigan, United States, 48109Ascension Genesys Hospital | Grand Blanc Michigan, United States, 48439The Heart House Haddon Heights | Haddon Heights New Jersey, United States, 08035Rutgers University - Robert Wood Johnson Medical School | New Brunswick New Jersey, United States, 08901University of New Mexico Health Science Center | Albuquerque New Mexico, United States, 87131University at Buffalo | Buffalo New York, United States, 14203Northwell Health - Manhasset | Manhasset New York, United States, 11030Mount Sinai Medical Cente | New York New York, United States, 10029Mid Carolina Cardiology Research | Charlotte North Carolina, United States, 28204Duke University | Durham North Carolina, United States, 27710-4000University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45267-0542Penn State Milton S Hershey Medical Center | Hershey Pennsylvania, United States, 17033Jefferson University Hospital | Philadelphia Pennsylvania, United States, 19107University of Pittsburgh Medical Center | Pittsburgh Pennsylvania, United States, 15213Stern Cardiovascular Center | Germantown Tennessee, United States, 38138Baylor University Medical Center | Dallas Texas, United States, 75246University of Miami Hospital | Miami Texas, United States, 33136University of Texas Health Science Center at San Antonio | San Antonio Texas, United States, 78229Angereds 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, 55185Blekingesjukhuset | Karlskrona , Sweden, 37185Hjärtmottagningen, Centralsjukhuset | Karlstad , Sweden, 65230Västmanlands sjukhus Köping | Köping , Sweden, Centralsjukhuset Kristianstad | Kristianstad , Sweden, Lasarettet i Landskrona | Landskrona , Sweden, Skaraborgs sjukhus i Lidköping | Lidköping , Sweden, Linköpings Universitetssjukhus | Linköping , Sweden, 58185VO Akut- och internmedicin, Skånes Universitetssjukhus | Lund , Sweden, 22185Capio Citykliniken | Lund , Sweden, FO Kranskärl/Svikt, Skånes Universitetssjukhus | Lund , Sweden, Hjärtavdelningen, Skånes Universitetssjukhus | Malmö , Sweden, 20502Kliniska forskningsenheten Skånes Universitetssjukhus | Malmö , Sweden, Mariefreds Vårdcentral | Mariefred , Sweden, Sahlgrenska University Hospital Mölndal | Mölndal , Sweden, Kardiologikliniken, Vrinnevisjukhuset | Norrköping , Sweden, 60182Oskarshamns 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, 11883Capio 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, 43281Västmanlands sjukhus Västerås | Västerås , Sweden, Västerviks sjukhus | Västervik , Sweden,
Investigators
Principal Investigator: Lars H Lund, MD, PhD, Karolinska InstitutetPrincipal Investigator: Bertram Pitt, University of Michigan