Heart Failure with Preserved Ejection Fraction (HFpEF) Clinical Trials

• Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular

• At least one of the following:

‣ N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.

⁃ Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.

• Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV).

• Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., myocardial infarction \[MI\] or heart failure \[HF\] hospitalisation).

• Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:

• Left atrial (LA) volume index greater than 34 milliliter per meter square (mL/m\^2).

• LA diameter greater than equal to 3.8 centimeter (cm).

• LA length greater than equal to 5.0 cm.

• LA area greater than equal to 20 cm square.

• LA volume greater than equal to 55 milliters (mL).

• Intraventricular septal thickness greater than equal to 1.1 cm.

• Posterior wall thickness greater than equal to 1.1 cm.

• Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m\^2 ) in men or greater than equal to 95 g⁄m\^2 in women.

• E/e' (mean septal and lateral) greater than equal to 10.

• e' (mean septal and lateral) less than 9 centimeter per second (cm/s).

• No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).