Unique ID issued by UMIN | UMIN000040347 |
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Receipt number | R000046042 |
Scientific Title | The Administration of Empagliflozin Can Prevent the Exacerbation of Renal Tubular Injury in Patients with Compensated Heart Failure Complicated by Diabetes Mellitus |
Date of disclosure of the study information | 2020/05/10 |
Last modified on | 2020/11/16 11:13:32 |
Role of Empagliflozin in Patients with Compensated Heart Failure Complicated by Diabetes Mellitus
Sodium-glucose cotransporter-2 inhibitor in Heart Failure
The Administration of Empagliflozin Can Prevent the Exacerbation of Renal Tubular Injury in Patients with Compensated Heart Failure Complicated by Diabetes Mellitus
sodium-glucose cotransporter-2 inhibitor in Patients with Compensated Heart Failure Complicated by Diabetes Mellitus
Japan |
Compensated Heart Failure
Cardiology |
Others
NO
One of the effects exerted by SGLT2 inhibitors is a diuretic effect, induced by increasing the urinary glucose content. We therefore posed the clinical question of whether or not the dose of loop diuretics can be reduced in HF patients being treated with an SGLT2 inhibitor. We hypothesized that an SGLT2 inhibitor would help prevent renal dysfunction, particularly renal tubular injury, by enabling a reduction in the dosage of loop diuretics in HF patients. To test this hypothesis, we conducted a multicenter center prospective study in patients with diabetic compensated HF who were already being treated with loop diuretics.
Safety,Efficacy
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.
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
2
Treatment
Medicine |
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 therapy except for empagliflozin use, and the treatment strategy was determined by each patient'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 administrated SGLT2 inhibitor within 6 month.
There were no limitations on HF therapy except for empagliflozin use, and the treatment strategy was determined by each patient's doctor. Two patients in the empagliflozin group dropped out during the six-month follow-up.
Not applicable |
Not applicable |
Male and Female
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.
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.
60
1st name | Akihiro |
Middle name | |
Last name | Shirakabe |
Nippon Medical School Chiba Hokusoh Hospital
Division of Intensive Care Unit
270-1694
1715 Kamagari, Inzai, Chiba 270-1694, Japan
0476-99-1111
s6042@nms.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Shitakabe |
Nippon Medical School Chiba Hokusoh Hospital
Division of Intensive Care Unit
270-1694
1715 Kamagari, Inzai, Chiba 270-1694, Japan
0476-99-1111
s6042@nms.ac.jp
Nippon Medical School Chiba Hokusoh Hospital
Ourselves
Other
the institutional review board of Nippon Medical School Chiba Hokusoh Hospital
1715 Kamagari, Inzai, Chiba 270-1694, Japan
0476-99-1111
araraki@nms.ac.jp
NO
2020 | Year | 05 | Month | 10 | Day |
Published
60
Main results already published
2018 | Year | 07 | Month | 31 | Day |
2018 | Year | 07 | Month | 02 | Day |
2018 | Year | 08 | Month | 15 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 05 | Month | 10 | Day |
2020 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046042
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