LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

Inclusion Criteria

• •Patients with documented stable chronic heart failure (NYHA II-IV):
• •* LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
• •* the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
• •Plasma NT-proBNP \> 500 pg/ml at Visit 1.
• •Patients with documented stable chronic heart failure (NYHA II-IV).
• •Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
• •Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
• •Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
• •Patients with at least one of the following symptoms at the time of screening (Visit 1):
• •* Dyspnea on exertion
• •* Orthopnea
• •* Paroxysmal nocturnal dyspnea
• •* Peripheral edema
• •Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
• •Patients with a potassium ≤5.2 mmol/l at Visit 1.