Health Condition 1: null- Heart Failure With Reduced Ejection Fraction
Conditions
Interventions
Intervention1: LCZ696 200 mg BID: Experimental: LCZ696 200 mg tab BID for 24 months
Control Intervention1: Enalapril 10 mg BID: Active Comparator: Enalapril 10 mg BID
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Patients must give written informed consent before any assessment is performed. •Outpatients greater than equal to 18 years of age, male or female. •Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF equal to lesser than 35percent) and elevated BNP. •Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks. •Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Exclusion criteria
Exclusion criteria: * Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs. * Previous history of intolerance to recommended target doses of ACEIs or ARBs * Known history of angioedema. * Requirement of treatment with both ACEIs and ARBs. * Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy). * Symptomatic hypotension and/or a SBP < 100 mmHg. * Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula * Serum potassium > 5.2 mmol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalizationTimepoint: Up to 4yrs | — |
Secondary
| Measure | Time frame |
|---|---|
| * Time to all-cause mortalityTimepoint: Up to 4yrs;* Time to occurrence of renal dysfunctionTimepoint: Up to 4yrs;â?¢ Change in the clinical summary score for HF symptoms and physical limitations (as assessed by KCCQ)Timepoint: Up to 4yrs | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, Iceland, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Panama, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Venezuela (Bolivarian Republic of)
Contacts
Public ContactMurugananthan K
Head-Clinical Development
Outcome results
None listed