UMIN-CTR Clinical Trial

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
Email	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
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030216