A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Inclusion Criteria:

Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch
Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
NYHA class II-IV
Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
KCCQ clinical summary score < 75
Patients on ACEi or ARB therapy must have a history of HTN

Exclusion Criteria:

Any prior measurement of LVEF ≤ 40%, under stable conditions
Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40%
Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
History of hypersensitivity to LCZ696 or its components
Patients with a known history of angioedema
Walk distance primarily limited by non-cardiac comorbid conditions at study entry
Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
Patients with HbA1c > 7.5% not treated for diabetes
Patients with prior major organ transplant or intent to transplant (ie on transplant list)
eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry
History or presence of any other disease with a life expectancy of < 3 years
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.