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Testing spironolactone for heart failure with preserved ejection fraction

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

Phase 3 Interventional Uppsala University · NCT02901184

This study is testing if adding spironolactone to standard care can help people with heart failure and preserved ejection fraction live longer and avoid hospital visits.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2000 (estimated)
Ages50 Years to 99 Years
SexAll
SponsorUppsala University Academic / other
Locations78 sites (Alexander City, Alabama and 77 other locations)
Trial IDNCT02901184 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of spironolactone in patients with heart failure with preserved ejection fraction (HFPEF) compared to standard care alone. It involves a registry-randomized design where participants will be assigned to receive either spironolactone plus usual care or usual care alone. The primary outcome will focus on cardiovascular mortality and hospitalizations due to heart failure. The study will include patients from the Swedish Heart Failure Registry and various sites in the US, ensuring a diverse population for analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 50 and older with stable heart failure symptoms, elevated natriuretic peptide levels, and an ejection fraction of 40% or higher.

Not a fit: Patients with an ejection fraction below 40% or those who have previously participated in this study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide a new therapeutic option for patients suffering from HFPEF, potentially reducing hospitalizations and improving survival rates.

How similar studies have performed: Previous studies have shown inconclusive results regarding spironolactone's effectiveness in HFPEF, making this approach both novel and necessary for further investigation.

Eligibility criteria

Show full inclusion / exclusion 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:

  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

Where this trial is running

Alexander City, Alabama and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure With Preserved Ejection Fraction
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.