Acute Heart Failure Empagliflozin, Acute Heart Failure
Conditions
Interventions
Among patients with acute heart failure, those who (1) have an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.72m2, (2) have already been treated with furosemide at a dose of 40
Sponsors
Matsue Yuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20 years and over If the patient is 90 years of age or older and cognitive decline is considered necessary, Mini-Cog should be used to confirm that its score is not less than 3. 2. Patients who have been hospitalized with a diagnosis of acute heart failure and require intravenous loop diuretic therapy, and meet all the following: i) Dyspnea at rest or induced by slight exertion ii) Have at least two of the following findings: jugular venous distention, pulmonary rales, lower leg edema, and pulmonary congestion on a plain film iii) If the patient has a sinus rhythm at the time of admission, brain natriuretic peptide (BNP) >=350 pg/mL or NT-proBNP >=1400 pg/mL; if the patient has atrial fibrillation at the time of admission, BNP >=500 pg/mL or NT-proBNP >=2000 pg/mL. 3. Patients who meet at least one of the following: i) Estimated glomerular filtration rate (eGFR) =40 mg of furosemide daily prior to hospitalization iii) Urine output of <300 mL during 2 h following an adequate dose of intravenous furosemide 4. Patients who have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. eGFR =130, persistent bradycardia with a ventricular response rate of <45, an infection, severe anemia, and an acute exacerbation of chronic obstructive pulmonary disease - COPD) 7. Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization. 8. Have a risk of ketoacidosis or hyperosmolar hyperglycemia 9. Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during hospitalization is planned 10. Pregnant or lactating women 11. Have undergone the following therapeutic intervention within 30 days: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge to edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, a cardiac resynchronization therapy defibrillator, or an implantable ventricular assist device 12. A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days 13. Findings of ventricular tachycardia with syncope revealed within 90 days 14. Heart transplant recipients or patients listed for heart transplantation who are expected to undergo transplantation during the present treatment, patients implanted with an implantable ventricular assist device, patients expected to require an implantable ventricular assist device during the present treatment, and patients expected to switch to palliative care 15. Patients intubated at the time of screening or patients expected to require intubation within 48 h after study drug administration 16. Severe valvular heart disease expected to be treated with thoracotomy or catheterization (there is no reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization) 17. Patients with a diagnosis of secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), or pericardial constriction 18. A diagnosis of peripartum cardiomyopathy made within 6 months 19. Active myocarditis 20. Presence of uncontrolled thyroid disease 21. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae) 22. Patients with symptomatic bradycardia or complete atrioventricular block who are being treated with temporary pacemaker implantation at the time of admission, or who are expected to require temporary pacemaker implantation in the future. Patients who have already been treated with permanent pacemaker implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Win ratio for a hierarchical composite endpoint consisting of death within 90 days of randomization, heart failure readmission within 90 days of randomization, heart failure re-exacerbation during hospitalization, and urine output up to 48 hours after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoints 1) Win ratio for a hierarchical composite endpoint consisting of death within 90 days of randomization, heart failure readmission within 90 days of randomization, and heart failure re-exacerbation during hospitalization 2) A composite endpoint consisting of in-hospital re-worsening heart failure, death within 90 days after randomization, heart failure rehospitalization, urgent visit for worsening heart failure, intensification of diuretic therapy after discharge, and worsening NYHA class after discharge 3) Group differences in NT-proBNP in geometric mean rate of changes after randomization and up to 48 hours 4) Diuretic response to per 40 mg furosemide by urine excretion up to 48 h after the start of treatment 5) Improvement of 5 points or more of Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) at 30 and 90 days after randomization Secondary Endpoints 1) Time to hemodynamic stabilization 2) Re-exacerbation of heart failure during hospitalization 3) Heart failure rehospitalization within 90 days of randomization 4) Death within 90 days of randomization 5) Urine output up to 48 hours after initiation of therapy 6) Cardiovascular death within 90 days of randomization 7) Change in visual analog scale (VAS) for dyspnea from randomization to 24, 48 hours after randomization 8) Between-group difference in geometric mean change in high-sensitivity troponin T from randomization to 48 hours 9) Change in KCCQ-TSS at 30 and 90 days after randomization 10) Composite endpoint of renal replacement therapy (ultrafiltration, hemofiltration, hemodialysis) , renal transplantation, estimated glomerular filtration rate (eGFR) 50% decrease in eGFR compared to the initial sample, and >2-fold increase in creatinine level compared to the initial sample within 90 days after randomization 11) eGFR at 24, 48 hours, 30 days, and 90 days after randomization 12) Days alive and out of hospital (including those for reasons other than heart failure) | — |
Contacts
Public ContactYuya Matsue
Juntendo University Hospital
Outcome results
None listed