UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026315 |
|---|---|
| Receipt number | R000030216 |
| Scientific Title | SGLT2 Inhibition in Patients With Type 2 Diabetes Mellitus and Acute Decompensated Heart Failure: SLIM-AHF Study |
| Date of disclosure of the study information | 2017/02/27 |
| Last modified on | 2020/09/14 20:42:05 |
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Basic information
Public title
SGLT2 Inhibition in Patients With Type 2 Diabetes Mellitus and Acute Decompensated Heart Failure: SLIM-AHF Study
Acronym
SLIM-AHF
Scientific Title
SGLT2 Inhibition in Patients With Type 2 Diabetes Mellitus and Acute Decompensated Heart Failure: SLIM-AHF Study
Scientific Title:Acronym
SLIM-AHF
Region
| Japan |
Condition
Condition
acute decompensated heart failure complicated with type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of Empagliflozin in patients with type 2 diabetes mellitus and acute decompensated heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 left to the discretion of each primary physician.
Interventions/Control_2
Conventional therapy group: Use of SGTL2 inhibitors is prohibited.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Tamaki |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
tamaki-shunsuke@mwc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Tamaki |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 05 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030216
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