Health Condition 1: null- Chronic Heart Failure with preserved Ejection Fraction (HFpEF) Health Condition 2: I508- Other heart failure
Conditions
Interventions
Intervention1: Empagliflozin: Dose: 10 mg q.d.
Mode of administration: per oral
Duration of Treatment: Approximately 20-38 months double-blind treatment until the
required number of adjudicated primar
Sponsors
Boehringer Ingelheim Pharma GmbH Co KG
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patient, age greater than or equal to 18 years at screening. For Japan only: Age Greater than or equal to 20 years at screening Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR Greater than 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1 Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1 Stable dose of oral diuretics, if prescribed Signed and dated written ICF (informed consent form) Further inclusion criteria apply
Exclusion criteria
Exclusion criteria: 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 (Heart Failure) Systolic blood pressure (SBP) greater than or equal to 180 mmHg at Visit 2. Symptomatic hypotension and/or a SBP less than 100 mmHg Indication of liver disease, Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) less than 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis History of ketoacidosis Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor Currently enrolled in another investigational device or drug trial 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 Further exclusion criteria may 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 Heart Failure with preserved Ejection Fraction (HFpEF).Timepoint: up to 38 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQTimepoint: week 52;eGFR (CKD-EPI)cr slope of change from baselineTimepoint: up to 38 months;Occurrence of adjudicated HHF (first and recurrent)Timepoint: up to 38 months;Occurrence of all-cause hospitalization (first and recurrent)Timepoint: up to 38 months;Time to adjudicated CV deathTimepoint: up to 38 months;Time to all-cause mortality- during the entire studyTime to onset of diabetes mellitus (DM) in patients with pre-DMTimepoint: up to 38 months;Time to first adjudicated HHFTimepoint: up to 38 months;Time to first occurrence of sustained reduction of ââ?°Â¥40% eGFR(CKD-EPI)cr or sustained eGFR (CKD-EPI)cr 15 mL/min/1.73 m2 for patients with baseline eGFR ââ?°Â¥30 mL/min/1.73 m2 of sustained eGFR (CKD-EPI)cr 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2Timepoint: up to 38 months | — |
Countries
Argentina, Australia, Brazil, Canada, China, Colombia, Czech Republic, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Romania, Singapore, South Africa, Spain, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS (I) Private Limited
Outcome results
None listed