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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8,442
LCZ696 200 mg BID
Enalapril 10 mg BID
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Time frame: up to 51 months
Number of Patients - All-cause Mortality
Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014
Time frame: up to 51 months
Number of Patients Reported With Adjudicated Primary Causes of Death
Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014
Time frame: up to 51 months
Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline, Month 8
Number of Patients With First Confirmed Renal Dysfunction
Number of patients with first confirmed renal dysfunction
Time frame: up to 51 months
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Huntsville, Alabama, United States
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Muscle Shoals, Alabama, United States
Novartis Investigative Site
Anchorage, Alaska, United States
Novartis Investigative Site
Gilbert, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
...and 1021 more locations
Percentage of Participants With New Onset of Atrial Fibrillation (AF)
Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).
Time frame: up to 51 months