acute heart failure
Conditions
Interventions
investigational material(s)
Generic name etc : Empagliflozin
INN of investigational material : Empagliflozin
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission 2.Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation 3.Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital4. 4.Patients must fulfil the following stabilisation criteria (while in the hospital): -SBP>=100mm Hg and no symptoms of hypotension in the preceding 6 hours, -no increase in i.v. diuretic dose for 6 hours prior to randomisation, -no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation -no i.v. inotropic drugs for 24 hours prior to randomisation. 5.Elevated NT-proBNP >= 1600pg/mL or BNP >=400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP >= 2400pg/mL or BNP >= 600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used 6.HF episode leading to hospitalisation must have been treated with a minimum dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide) 7.Further Inclusion Criteria Apply
Exclusion criteria
Exclusion criteria: 1.Cardiogenic shock 2.Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI) 3.Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload; 4.Below interventions in the past 30 days prior to randomisation or planned during the study: - Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip - All other surgeries that are considered major according to investigator judgement - Implantation of cardiac resynchronisation therapy (CRT) device - cardiac mechanical support implantation - Carotid artery disease revascularisation (stent or surgery) 5.Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation 6.Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting 7.Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study) 8.Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis 9.Type 1 Diabetes Mellitus (T1DM) 10.History of ketoacidosis, including diabetic ketoacidosis (DKA) 11.Further Exclusion Criteria Apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 1.The net clinical benefit, hierarchical composite endpoint composed of time to death, number of heart failure events (HFEs), time to first HFE, change in KCCQ-CSS from baseline after 90 days of treatment [ Time Frame: Baseline and after 90 days of treatment ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Proportion of patients with an improvement in KCCQ-CSS of >= 10 points [Time Frame: After 90 days of treatment] Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) 2.Change from baseline in KCCQ-CSS after 90 days of treatment [Time Frame: Baseline and after 90 days of treatment] Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) 3.Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) level over 30 days of treatment (area under the curve (AUC)) [Time Frame: Baseline and after 30 days of treatment] 4.Days alive and out of hospital from study drug initiation until 30 days after initial hospital discharge [Time Frame: 30 days after initial hospital discharge] 5.Days alive and out of hospital from study drug initiation until 90 days after randomisation [Time Frame: 90 days after randomisation] 6.Time to first occurrence of CV death or HFE until end of trial visit [Time Frame: Up to day 97] 7.Occurrence of HHF until 30 days after initial hospital discharge [Time Frame: 30 days after initial hospital discharge] 8.Occurrence of chronic dialysis or renal transplant or sustained1 reduction of >= 40% eGFR Chronic Kidney Disease Epidemiology Collaboration Equation ((CKD-EPI)cr) [Time Frame: Up to day 97] or -sustained eGFR (CKD-EPI)cr = 30 mL/min/1.73 m2 -sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30 mL/min/1.73 m2 9.Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 15 days of treatment [Time Frame: After 15 days of treatment] 10.Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 30 days of treatment [Time Frame: After 30 days of treatment] | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed