Compensated Heart Failure
Conditions
Interventions
The presence of empagliflozin administration. Empagliflozin was started at 10 mg per day and increased to 25 mg per day after the first evaluation of tolerability. There were no limitations on HF th
s doctor. Two patients in the empagliflozin group dropped out during the six-month follow-up.
The presence absence of empagliflozin administration. The patients in control group were not administrat
s doctor. Two patients in the empagliflozin group dropped out during the six-month follow-up.
Sponsors
Nippon Medical School Chiba Hokusoh Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic compensated HF patients who visited the outpatient clinics were prospectively enrolled in this study. HF was diagnosed by the treating physician at the outpatient clinic according to the European Society of Cardiology (ESC) guidelines for the diagnosis of HF. Enrolled patients were diagnosed chronic HF or have a history of acute HF at the enrolled date and were assessed as having compensated HF. All patients were administered loop diuretics (furosemide and/or trasemide and/or azosemide) at the start date of the study.
Exclusion criteria
Exclusion criteria: The patients were excluded as follows; 1. History of the hypersensitivity to SGLT2 inhibitor 2. Diabetic coma 3. Severe infectious disease 4. The physician decided to be impossible to administrate the SGLT2 inhibitor 5. Did not obtain the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-dependent changes in the laboratory and urinary data (including cardiac biomarkers and urinary biomarkers) as well as medication for DM and for HF (including the dose of loop diuretics) were evaluated between the start date and six months in both the empagliflozin and control groups. The urine and blood samples were collected on the day when consent was obtained (start date) and at the follow-up examination after six months (six months). The serum levels of heart-type fatty acid-binding protein (HFABP) and brain-type natriuretic peptide (BNP) were measured as cardiac biomarkers. In addition, the neutrophil gelatinase-associated lipocalin (NGAL), urine liver fatty acid-binding protein (LFABP), and acetyl-beta-D glucosaminidase (NAG) excretion was also measured as urinary renal tubular biomarkers. These urine and serum biomarkers were measured by the Special Reference Laboratory (SRL, Tokyo, Japan). The level of urinary LFABP was measured with an enzyme-linked immunosorbent assay (ELISA) using a human LFABP ELISA kit (Kyowa Medex Co., Tokyo, Japan). The level of urinary NGAL was measured using the NGAL ELISA Kit (R&D Systems, Inc., Minneapolis, MN, USA). The lower and upper limits of detection for the urinary NGAL concentration were 4 and 500 pg/ml, respectively, and the lower limit for the u-LFABP was 2.9 pg/ml. | — |
Countries
Japan
Contacts
Public ContactAkihiro Shitakabe
Nippon Medical School Chiba Hokusoh Hospital Division of Intensive Care Unit
Outcome results
None listed