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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031563
Receipt No. R000035848
Scientific Title Effect of canagliflozin as an alternative drug from DPP-4 inhibitor on heart failure with diabetis melltus : the pilot study "Can canagliflozin HAve Not only hypoGlycemic but cardiac supportive Effect?"
Date of disclosure of the study information 2018/03/04
Last modified on 2018/03/03

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Basic information
Public title Effect of canagliflozin as an alternative drug from DPP-4 inhibitor on heart failure with diabetis melltus : the pilot study "Can canagliflozin HAve Not only hypoGlycemic but cardiac supportive Effect?"
Acronym CHANGE trial
Scientific Title Effect of canagliflozin as an alternative drug from DPP-4 inhibitor on heart failure with diabetis melltus : the pilot study "Can canagliflozin HAve Not only hypoGlycemic but cardiac supportive Effect?"
Scientific Title:Acronym CHANGE trial
Region
Japan

Condition
Condition chronic heart failure with type 2 diabetis mellitus
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of canagliflozin as an alternative drug from DPP-4 inhibitor in heart failure with diabetis using BNP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of BNP at 6 months from baseline
Key secondary outcomes 1. Vital signs
2. Labolatory data: blood and urinary biomarkers
3. Cardiac function
4. Cardiac vascular event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Change group: Start with canagliflozin 100mg/day and stop or reduce DPP-4 inhibitor for 6 months.
Interventions/Control_2 Non-Change group: Conventional therapy for diabetes and heart failure
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. Treated with DPP4 inhibitor
2. Heart failure patients with type 2 diabetes mellitus who have HbA1c 6.5% or more
Key exclusion criteria 1. End stage renal failure including eGFR<15ml/min/1.73m2 or dialytic therapy
2. Treated with SGLT2 inhibitor
3. Contraindications of SGLT2 inhibitor
4. Type 1 diabetes mellitus
5. The pregnant, breast feeder
6. BMI<18.5kg/m2
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyosuke Yanagawa
Organization Osaka Rosai Hospital
Division name Division of Cardiology
Zip code
Address 1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
TEL 072-252-3561
Email k.yanagawa0217@osakah.johas.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyosuke Yanagawa
Organization Osaka Rosai Hospital
Division name Division of Cardiology
Zip code
Address 1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
TEL 072-252-3561
Homepage URL
Email k.yanagawa0217@osakah.johas.go.jp

Sponsor
Institute Osaka Rosai Hospital
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
2018 Year 03 Month 04 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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
2018 Year 03 Month 03 Day
Last modified on
2018 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035848

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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