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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027095
Receipt No. R000030942
Scientific Title Examination for Cardiac function Effect by Echocardiography in Diabetes with chronic heart failure
Date of disclosure of the study information 2017/07/01
Last modified on 2017/10/22

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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
Middle name
Last name Hiromi Rakugi
Organization Osaka University Graduate School of Medicine
Division name Geriatric and General Medicine
Zip code
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
Middle name
Last name Ken Sugimoto
Organization Osaka University Graduate School of Medicine
Division name Geriatric and General Medicine
Zip code
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
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 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
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
2017 Year 10 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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