UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027095 |
|---|---|
| Receipt number | 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 | 2020/10/25 21:56:07 |
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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 | 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
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
sugimoto@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030942
