UMIN-CTR Clinical Trial

Basic information
Public title	Examination for Cardiac function Effect by Echocardiography in Diabetes with chronic heart failure
Acronym	EXCEED
Scientific Title	Examination for Cardiac function Effect by Echocardiography in Diabetes with chronic heart failure
Scientific Title:Acronym	EXCEED
Region	Japan

Condition
Condition	diabetes Mellitus and chronic heart failure
Classification by specialty	Cardiology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate the effect of Ipragliflozin L-Proline (Suglat) on cardiac function in patients with both chronic heart failure and diabetes who have an HbA1c of 7.0%(age65>=,7.5%) or higher in a randomized two-arm comparison design.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in echocardiography-based cardiac function test parameters( E/e',e')
Key secondary outcomes	Change in echocardiography-based cardiac function test parameters (LVMI,LAD,LAV,LVEF,LVEDV,LVESV,E/A,IVC) Change in NT-proBNP Change in NYHA Functional Classification and other assessments

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A arm to which an additional dose of Ipragliflozin L-Proline was administered.
Interventions/Control_2	Regular anti-diabetic drugs other than SGLT-2 inhibitors arm.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.diabetes Mellitus with NT-proBNP> 125 pg / mL and chronic heart failure (NYHA function classification 1 - 3). 2.Within the last 3 months,not administered the SGLT2 inhibitor. 3.Aged < 65years:HbA1c 7%<=and < 10% ,Aged >= 65years:HbA1c 7.5%<= and < 10%. 4.Aged >= 20 and < 75years. 5.Outpatient. 6.Any gender. 7.Provision of written consent.
Key exclusion criteria	1.Acute exacerbation patients with chronic heart failure. 2.Within 3 months,stroke,Acute coronary syndrome,And percutaneous coronary angioplasty,coronary artery bypass surgery. 3.LVEF<50% and Severe valvular disease. 4.Concurrent Atrial fibrillation. 5.Severe liver dysfunction(Chronic hepatitis C etc). 6.Severe Kidney failure or eGFR <30mL/min/1.73m2 7.Concurrent malignancy. 8.Concurrent dementia. 9.State requiring nursing care. 10.Pregnancy or possible pregnancy. 11.SGLT2 inhibitors medicine contraindications. 12.Inappropriateness as a subject of this trial as determined by the investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Rakugi
Organization	Osaka University Graduate School of Medicine
Division name	Geriatric and General Medicine
Zip code	565-0871
Address	2-2, Yamada-oka, Suita, Osaka
TEL	06-6879-3852
Email	rakugi@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Sugimoto
Organization	Osaka University Graduate School of Medicine
Division name	Geriatric and General Medicine
Zip code	565-0871
Address	2-2, Yamada-oka, Suita, Osaka
TEL	06-6879-3852
Homepage URL
Email	sugimoto@geriat.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kotobuki pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Academic Clinical Research Center of Osaka University Hospital
Address	2-15, Yamada-oka, Suita, Osaka, Japan
Tel	06-6879-5111
Email	k-yoneda@dmi.med.osaka-u.ac.jp

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 07 Month 01 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	Completed
Date of protocol fixation	2017 Year 03 Month 26 Day
Date of IRB	2017 Year 06 Month 13 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 21 Day
Last modified on	2020 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030942