Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

Inclusion Criteria:

- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or
within 6 months prior to study entry.

- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at
least 30 days prior to study entry.

- Current symptom(s) of HF

- Structural heart disease (left atrial enlargement or left ventricular hypertrophy)
documented by echocardiogram.

- Elevated NT-proBNP

Exclusion Criteria:

- Any prior measurement of LVEF < 40%.

- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within
3 months , or urgent percutaneous coronary intervention within 3 months or and
elective PCI within 30 days prior to entry.

- Any clinical event within the 6 months prior to entry could have reduced the LVEF
(e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF
≥45%.

- Current acute decompensated HF requiring therapy.

- Patients who require treatment with 2 or more of the following: an angiotensin
converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin
inhibitor.

- Alternative reason for shortness of breath such as: significant pulmonary disease or
severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.

- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at
entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110
mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.