Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
With
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
