Health Condition 1: null- Chronic Heart Failure
Conditions
Interventions
Intervention1: LCZ696: 50 mg titrated to 100 mg and 200 mg
Control Intervention1: Valsartan: 40 mg titrated to 80 mg and 160 mg
Sponsors
Novartis
Eligibility
Inclusion criteria
Inclusion criteria: Patients with documented stable chronic heart failure (NYHA II-IV): 1)LVEF greater than equal to 45percent (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography) 2)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 greater than 500 pg per ml at Visit 1. Patients with documented stable chronic heart failure (NYHA II-IV). 3)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. 4)Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted). 5)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). 6)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 7)Patients must have an eGFR greater than equal to 30 ml per min per 1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula). 8)Patients with a potassium less than equal to 5.2 mmol per l at Visit 1.
Exclusion criteria
Exclusion criteria: 1)Patients with a prior LVEF reading 45%, at any time. 2)Patients who require treatment with both an ACE inhibitor and an ARB. 3)Isolated right heart failure due to pulmonary disease. 4)Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity. 5)Presence of hemodynamically significant mitral and per or aortic valve disease. 6)Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis. 7)Presence of hypertrophic obstructive cardiomyopathy. 8)Other protocol-defined inclusion or exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in log-scale in NT-proBNPTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical composite score (NYHA and global patient assessment score) time frameTimepoint: 12 weeks;Change in echocardiography parametersTimepoint: 12 weeks;Change in log-scale in BNP, MR-proBNP, cGMPTimepoint: 12 weeks;Change in the overall summary score and individual domain score of the Kansas City Cardiomyopathy questionnaireTimepoint: 12 weeks;Class indicators of signs and symptoms of heart failure at each visitTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed