This study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality of patients with chronic heart failure.

• Conditions: Chronic Heart Failure; MedDRA version: 15.1Level: LLTClassification code 10008502Term: CHFSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-015834-31-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7980

Inclusion Criteria

1. Patients must give written informed consent before any assessment is performed.
2. Outpatients = 18 years of age, male or female.
3. Patients with a diagnosis of CHF NYHA class, II-IV, reduced ejection fraction (EF = 35%) and elevated BNP.
4. 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
5. Patients must be treated with a ß-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks
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 4200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4200

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. 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
3. Previous history of intolerance to recommended target doses of ACEIs or ARBs
4. Known history of angioedema
5. Requirement of treatment with both ACEIs and ARBs
6. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
7. Symptomatic hypotension and/or a SBP < 100 mmHg
8. Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if LCZ696 is superior to enalapril in delaying time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization;Secondary Objective: • To test if LCZ696 improves the clinical summary score for HF symptoms and physical limitations (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]). <br>• To test if LCZ696 delays the time to all-cause mortality.<br>• To test if LCZ696 delays the time to occurrence of renal dysfunction.<br>• To test if LCZ696 delays the time to new onset atrial fibrillation (AF). <br>;Primary end point(s): Time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization;Timepoint(s) of evaluation of this end point: Up to 4 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in the clinical summary score for HF symptoms and physical limitations (as assessed by KCCQ). <br>Time to all-cause mortality.<br>Time to occurrence of renal dysfunction.<br>Time to new onset of atrial fibrillation. <br><br><br>;Timepoint(s) of evaluation of this end point: Up to 4 years