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About
The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
Signed and dated written ICF (Informed Consent Form)
Further inclusion criteria apply
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
3,730 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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