Health Condition 1: null- Chronic Heart Failure with reduced Ejection Fraction (HFrEF) Health Condition 2: I508- Other heart failure
Conditions
Interventions
Intervention1: Test product: Empagliflozin
: Dose: 10 mg q.d.
Mode of administration: per oral
Control Intervention1:
Comparator product: Placebo
: Test product: Empagliflozin
Dose: 10 mg q.d.
Mod
Sponsors
Boehringer Ingelheim Pharma GmbH Co KG
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated Hospitalisation for Heart Failure in patients with HFrEF.Timepoint: 38 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Time to onset of diabetes mellitus (DM) in patients with pre-DMTimepoint: week 148;Time to first event of sustained reduction of ââ?°Â¥40% eGFR (CKD-EPI) or ââ?¬Â¢sustained eGFR (CKD-EPI) 15 mL/min/1.73 m2 for patients with baseline eGFR ââ?°Â¥30 mL/min/1.73 m2Timepoint: During entire study;ââ?¬Â¢ Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQTimepoint: week 52;ââ?¬Â¢ sustained eGFR (CKD-EPI) 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2Timepoint: During entire study;ââ?¬Â¢eGFR (CKD-EPI) slope of change from baselineTimepoint: During entire study;ââ?¬Â¢Occurrence of adjudicated HHF (first and recurrent)Timepoint: During entire study;ââ?¬Â¢Occurrence of all-cause hospitalisation (first and recurrent)Timepoint: during entire study;ââ?¬Â¢Time to adjudicated CV deathTimepoint: During entire study;ââ?¬Â¢Time to all-cause mortalityTimepoint: During entire study;ââ?¬Â¢Time to first adjudicated HHFTimepoint: During entire study | — |
Countries
Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Spain, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS (I) PVT. LTD.,
Outcome results
None listed