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Spironolactone for Heart Failure with Preserved Ejection Fraction (SPIRRIT Trial)

This study is investigating if adding spironolactone to standard care can help people with heart failure with preserved ejection fraction (HFPEF). HFPEF means your heart can pump blood normally, but it's too stiff to fill properly. Currently, there isn't a specific treatment for HFPEF. This trial will compare spironolactone plus standard care to standard care alone. Researchers want to see if spironolactone can reduce the number of hospitalizations for heart failure or deaths from heart problems. You may be able to join if you are 50 to 99 years old, have stable heart failure with a specific heart pumping ability (LVEF ≥40%), and elevated natriuretic peptide levels (a biomarker indicating heart strain). The study aims to enroll 2000 participants. The current status of the study is unclear.

Study design
This is an interventional study that will compare two groups: one receiving spironolactone plus standard care, and another receiving standard care alone. It plans to enroll 2000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed continuously until five years after the study starts, with data collected at database lock.

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NCT02901184

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

Recruiting
PHASE3Ages 50–99InterventionalTreatment
Uppsala University
~2,000 participants
Updated 2024-10-22 on ClinicalTrials.gov
What's tested:SpironolactoneStandard care

At a glance

Recruiting sites
29 of 78 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
Measured over Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

Conditions

Heart Failure With Preserved Ejection Fraction

Explore related trials

Heart failure with normal ejection fractionNPPB wt AlleleN-Terminal Fragment Brain Natriuretic Protein

Where it's being run

78 sites across 21 states
Sweden40
Illinois4
Massachusetts4
New York3
Pennsylvania3
Texas3
Alabama2
District of Columbia2

Study leadership

  • Lars H Lund, MD, PhD · PRINCIPAL_INVESTIGATOR · Karolinska Institutet
  • Bertram Pitt · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Anna Gustavsson (SWE)
[email protected]
+46186110181
Email the study team

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Eligibility criteria

Inclusion

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:
Regular use of loop diuretics, defined as daily or most days of the week
NYHA Class II-IV

Exclusion

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

What this trial measures

  • Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) deathCollected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

    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