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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)
If EF \>= 36% to \<= 40%: NT-proBNP \>= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP \>= 5000 pg/ml for patients with AF
If EF \>= 31% to \<= 35%: NT-proBNP \>= 1000 pg/ml for patients without AF and NT-proBNP \>=2000 pg/ml for patients with AF
If EF\<= 30%: NT-proBNP \>= 600 pg/ml for patients without AF and NT-proBNP \>=1200 pg/ml for patients with AF
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP \>= 1200 pg/ml for patients with AF
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)

Criterios de exclusión

Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
Heart transplant recipient, or listed for heart transplant
Acute decompensated HF
Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.
Symptomatic hypotension and/or a SBP \< 100 mmHg
Indication of liver disease
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
History of ketoacidosis
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
Currently enrolled in another investigational device or drug study
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Ubicaciones

Hospital Interzonal General de Agudos Dr Jose Penna

Bahía Blanca, Argentina

Hospital Italiano Regional del Sur, Bahia Blanca

Bahía Blanca, Argentina

CIPREC

CABA, Argentina

Hospital Italiano de Buenos Aires

CABA, Argentina

Consultorios Asociados de Endocrinología e Invest Clínica

Ciudad Autonoma Buenos Aires, Argentina

Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

CCBR - Buenos Aires - AR

Ciudad Autonoma Buenos Aires, Argentina

Centro Médico Viamonte

Ciudad Autonoma de Bs As, Argentina

Sanatorio Güemes

Ciudad Autónoma de Bs As, Argentina

Instituto Medico Elsa Perez SRL (IMEP)

Ciudadela, Argentina

Clinica Coronel Suarez SA

Coronel Suárez, Argentina

Instituto de Cardiología de Corrientes

Corrientes, Argentina

Sanatorio Mayo Privado SA

Córdoba, Argentina

Centro de Investigaciones Clinicas Instituto del Corazon

Córdoba, Argentina

Sanatorio Allende S.A.

Córdoba, Argentina

Clínica Colombo

Córdoba, Argentina

Instituto Médico DAMIC S.R.L.

Córdoba, Argentina

Hospital Privado

Córdoba, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Centro de Investigaciones Médicas

Mar del Plata, Argentina

Hospital Privado de Comunidad

Mar del Plata, Argentina

Clínica Olivos

Olivos, Argentina

CER Instituto Médico

Quilmes, Argentina

Instituto de Investigaciones Clínicas de Quilmes

Quilmes, Argentina

Instituto de Investigaciones Clinicas de Rosario

Rosario, Argentina

Instituto Medico Fundación Grupo Colaborativo Rosario

Rosario, Argentina

Sanatorio Británico

Rosario, Argentina

Sanatorio Plaza

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

Instituto CAICI

Rosario, Argentina

CORDIS S.A., Salta

Salta, Argentina

Centro Cardiovascular Salta

Salta, Argentina

Corporacion Medica de Gral. San Martin S.A.

San Martín, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Argentina

Instituto de Cardiología

San Miguel de Tucumán, Argentina

CCBR Tucuman

San Miguel de Tucumán, Argentina

Centro Medico Luquez

San Vicente, Argentina

Centro de Investigaciones Clínicas del Litoral

Santa Fe, Argentina

Hospital "Dr. José Maria Cullen "

Santa Fé, Argentina

CEMEDIC - Centro de Especialidades Medicas

Villa Luro, Argentina

A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Empagliflozin

Placebo

Ubicaciones

Hospital Interzonal General de Agudos Dr Jose Penna

Hospital Italiano Regional del Sur, Bahia Blanca

CIPREC

Hospital Italiano de Buenos Aires

Consultorios Asociados de Endocrinología e Invest Clínica

Instituto Cardiovascular de Buenos Aires

CCBR - Buenos Aires - AR

Centro Médico Viamonte

Sanatorio Güemes

Instituto Medico Elsa Perez SRL (IMEP)

Clinica Coronel Suarez SA

Instituto de Cardiología de Corrientes

Sanatorio Mayo Privado SA

Centro de Investigaciones Clinicas Instituto del Corazon

Sanatorio Allende S.A.

Clínica Colombo

Instituto Médico DAMIC S.R.L.

Hospital Privado

Hospital Italiano de La Plata

Centro de Investigaciones Médicas

Hospital Privado de Comunidad

Clínica Olivos

CER Instituto Médico

Instituto de Investigaciones Clínicas de Quilmes

Instituto de Investigaciones Clinicas de Rosario

Instituto Medico Fundación Grupo Colaborativo Rosario

Sanatorio Británico

Sanatorio Plaza

Sanatorio Parque

Instituto CAICI

CORDIS S.A., Salta

Centro Cardiovascular Salta

Corporacion Medica de Gral. San Martin S.A.

Investigaciones Clinicas Tucuman

Instituto de Cardiología

CCBR Tucuman

Centro Medico Luquez

Centro de Investigaciones Clínicas del Litoral

Hospital "Dr. José Maria Cullen "

CEMEDIC - Centro de Especialidades Medicas

Patrocinadores