Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: chronic heart failure cardiovascular death hospitalization outcome study BNP KCCQ eGFR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8442
Healthy volunteers: no

Brief summary:
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).

Detailed description:

Arms:
arm 1: single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period arm 2: single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period

Interventions: intervention 1: LCZ696 200 mg BID intervention 2: Enalapril 10 mg BID
Intervention descriptions: intervention 1: LCZ696 200 mg BID intervention 2: Enalapril 10 mg BID

Protocol document: