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

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