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

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 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

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

Value
https://center6.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