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 bylocal 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 ofblood 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 attime 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 mostrecent 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 receptorantagonist) 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 requirementfor 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 RenalDisease) < 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 mineralocorticoidreceptor antagonist is studied

• Any condition that in the opinion of the Investigator may interfere with adherenceto trial protocol