Heart Failure with reduced ejection fraction (HF-rEF) stabilized after hospitalization due to acute decompensated heart failure episode. MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Sponsors
Novartis Pharma services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients hospitalized due to acute decompensated HF episode (ADHF) - Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction - Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to randomization - Stabilized (while in the hospital) for at least 24 hours leading to randomization - Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1445
Exclusion criteria
Exclusion criteria: - Symptomatic hypotension and/or a SBP 180 mm Hg prior to randomization - End stage renal disease at ccreening; or estimated GFR 5.4 mmol/L at randomization. - Current hospitalization where patient does not receive treatment for decompensated HF. - Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy - Severe hepatic impairment, biliary cirrhosis and cholestasis - Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the primary objective of this study is to evaluate the proportion of patients in the Pre- and Post-discharge treatment initiation groups achieving the target dose of 200 mg LCZ696 twice daily at the end of the week-10 after randomization (Treatment Epoch), regardless of previous temporary dose interruption or down-titration.;Primary end point(s): The proportion of patients who achieve 10 weeks up-titration success;Timepoint(s) of evaluation of this end point: 10 weeks after randomization; Secondary Objective: - To assess the proportion of patients that, regardless of previous dose interruption or downtitration during the Treatment Epoch, achieved and maintained either the dose of 100 mg and/or 200 mg LCZ696 bid. - To asssess the proportion of patients that, regardless of previous dose interruption or downtitration during the Treatment Epoch, achieved and maintained any dose of LCZ696. - To assess the proportion of patients permanently discontinued from study drug, due to Adverse Events during the 10-week Treatment Epoch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assess the proportion of patients achieving and maintaining either the dose of 100 mg and/or 200 mg LCZ696 bid for at least 2 weeks leading to week 10 after randomization. - Assess the proportion of patients achieving and maintaining any dose of LCZ696 for at least 2 weeks leading to week 10 after randomization. - Assess the proportion of patients permanently discontinuation from study drug, at any time between randomization and week 10. ;Timepoint(s) of evaluation of this end point: 10 weeks after randomization | — |
Countries
Argentina, Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Hungary, Italy, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed