NCT02901184.

Trial name or title	Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction, SPIRRIT‐HFPEF
Methods	Study design: parallel, open‐label, RCT Anticipated start date: December 2017 Anticipated completion date: June 2022
Participants	Estimated enrolment: 3500 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) NT‐proBNP (the N‐terminal prohormone of brain natriuretic peptide) >300 ng/L in sinus rhythm or >750 ng/L in atrial fibrillation as an outpatient or prior to hospital discharge 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 Any condition other than heart failure with a life expectancy < 3 years Known chronic liver disease Probable alternative explanations for symptoms:Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)Primary hemodynamically significant valve diseaseRight‐sided HF not due to left‐sided HFSignificant chronic pulmonary disease defined by Investigator or by requirement for home O2 or oral steroids,Hemoglobin < 10 g/dL (100 g/L )BMI (body mass index) > 40Heart rate > 105 bpmAny other condition judged by Investigator to be responsible for symptoms and/or signs Heart transplant or LVAD (left ventricular assist device) recipient Systolic blood pressure <90 or >160 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 Actual or potential for pregnancy Participation in another clinical trial where treatment for HF is studied Any condition that in the opinion of the Investigator may interfere with adherence to trial protocol
Interventions	Spironolactone versus standard care
Outcomes	Primary: Time to death from any cause [Time Frame: Collected at data base lock, five (5) years after study start] Secondary: Time to first hospitalization for heart failure [Time Frame: Collected at data base lock, five (5) years after study start ]
Starting date	December 2017
Contact information	Inger Ekman (inger.ekman@ucr.uu.se)
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