To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,002
LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.
Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
Time frame: 10 weeks after Randomization
Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid
Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10
Time frame: 10 weeks after Randomization
Percentage of Patients Achieving and Maintaining Any Dose of LCZ696
Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment
Time frame: 10 weeks after Randomization
Percentage of Patients Permanently Discontinued From Treatment
Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons
Time frame: 10 weeks after Randomization AND 26 weeks after randomization
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Novartis Investigative Site
Quilmes, Buenos Aires, Argentina
Novartis Investigative Site
Villa María, Córdoba Province, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Córdoba, Argentina
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Salta, Argentina
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San Miguel de Tucumán, Argentina
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Brussels, Belgium
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Genk, Belgium
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Huy, Belgium
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