acute decompensated heart failure complicated with type 2 diabetes mellitus
Conditions
Interventions
Empagliflozin group: Empagliflozin is started from an initial dose of 10 mg/day, and the maximum dose is set at 15mg/day. The choice of therapy, including up- or down-titration of empagliflozin, is le
Sponsors
Osaka General Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of heart failure as defined by the presence of at least one symptom (dyspnea, orthopnea, edema) and one sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) 2) Patients with the diagnosis of acute decompensated heart failure made within 24 hours of hospital admission 3) Patients newly diagnosed with type 2 diabetes mellitus (HbA1c >=6.5% and <=12.0%) or those who had already been diagnosed with type 2 diabetes mellitus (HbA1c >=6.0% and <=12.0%) in whom diabetes medication can be modified 4) Patients with estimated glomerular filtration rate >=15mL/min/1.73m2 5) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Exclusion criteria
Exclusion criteria: 1) Patients with severe primary valvular heart disease 2) Patients with acute coronary syndrome 3) Patients with heart transplantation 4) Patients who do not need diuretic therapy because of dehydration 5) Patients with cardiogenic shock at eligibility qualification 6) Patients with intubation and mechanical ventilation at eligibility qualification 7) Patients who need mechanical circulatory assist device (IABP, PCPS) at eligibility qualification 8) Patients with myocarditis 9) Patients with hypertrophic obstructive cardiomyopathy 10) Patients with type 1 diabetes mellitus 11) Patients with reduced endogenous insulin secretion (fasting C-peptide level <1.0 ng/mL) 12) Patients who had already been on SGLT2 inhibitors 13) Patients with severe diabetic ketoacidosis or diabetic coma 14) Patients with a history of hypersensitivity reaction to empagliflozin 15) Patients who cannot have diet or receive enteral nutrition therapy within 96 hours of admission 16) Patients who are pre or post surgery, or patients with severe infection or serious trauma 17) Patients whose life expectancy is less than 6 months due to extracardiac disease 18) Patients with severe renal dysfunction (estimated glomerular filtration rate <15mL/min/1.73m2) or those with dialysis 19) Patients with a history of acute coronary syndrome, stroke or transient ischemic attack within one month of eligibility qualification 20) Pregnant, possibly pregnant or lactating women 21) Patients who were judged inappropriate by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NT-proBNP levels from baseline to 3 days, 7 days, the day just before discharge, 6 months, 18 to 24 months, and 30 to 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Vital signs: blood pressure, heart rate, body weight 2) Visual analogue scale: patient global assessent, dyspnea 3) Blood biomarkers: three fractions of catecholamine, renin activity, aldosterone, high-sensitivity troponin I, HbA1c, glycoalbumin, fasting insulin 4) Urinary biomarkers: urine osmolality, urinary excretion of sugar, urinary excretion of sodium, urinary albumin index, beta-2 microglobulin, L-FABP, urinary excretion of uric acid 5) Transthoracic echocardiography: LVEF, LVDd/Ds, E/e', LAD 6) Cardiac MIBG imaging: H/M MIBG uptake ratio on the delayed images, washout rate of cardiac MIBG 7) Cardiac MRI: LVEDV, LVESV, LVEF, LV mass, RVEDV, RVESV, RVEF, LA volume 8) Simultaneous blood pressure measurement at the bilateral upper arms and bilateral ankles: CAVI, PWV 9) Cardiovascular event 10) Acute kidney injury | — |
Countries
Japan
Contacts
Public ContactShunsuke Tamaki
Osaka General Medical Center Division of Cardiology
Outcome results
None listed