A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.
Inclusion Criteria:
Patients with documented stable chronic heart failure (NYHA II-IV):
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):
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.
Exclusion Criteria:
Caba, Buenos Aires C1408INH, Argentina
Ciudad Autonoma de Bs As, Buenos Aires C1119ACN, Argentina
Hyderabad, Andhra Pradesh 500012, India
Warszawa/Anin, Poland 04-761, Poland
S.-Petersburg, 196247, Russia