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). - NAP

Boehringer Ingelheim Pharma GmbH Co KG0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Male or female patient age Greater then or equal to 18 years at screening. For Japan only: Age Greater than or equal to 20 years at screening
•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, unless it is implanted within 3 months prior to Visit 1
•Signed and dated written ICF (Informed Consent Form)
•Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class 2-4 and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) less than equal to 40 percent) and elevated NT-pro BNP (N-terminal of the prohormone brain natriuretic peptide)
•-If EF greater then equal to 36 percent to less than equal to 40 percent NT-pro BNP greater then equal to 2500 pg per ml
•-If EF greater then equal to 31 percent to less than equal to 35 percent NT-proBNP greater than equal to 1000 pg per ml
•-If EF less than equal to 30% NT-proBNP greater than equal to 600 pg per ml

•1. 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 2. Heart transplant recipient, or listed for heart transplant 3. Acute decompensated HF 4. Systolic blood pressure (SBP) greater than equal to 180 mmHg at Visit 2. 5. Symptomatic hypotension and/or a SBP less than 100 mmHg 6. Indication of liver disease 7. Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) less than 20 mL per min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis 8. History of ketoacidosis 9. Treatment with any SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor 10. Currently enrolled in another investigational device or drug study 11. Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors 12. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 13. Further exclusion criteria apply

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