UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031563 |
|---|---|
| Receipt number | 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 | 2021/03/12 21:41:09 |
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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 | Kyosuke |
| Middle name | |
| Last name | Yanagawa |
Organization
Osaka Rosai Hospital
Division name
Division of Cardiology
Zip code
5918025
Address
1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
TEL
072-252-3561
k.yanagawa0217@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yanagawa |
Organization
Osaka Rosai Hospital
Division name
Division of Cardiology
Zip code
5918025
Address
1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
TEL
072-252-3561
Homepage URL
k.yanagawa0217@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
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
Osaka Rosai Hosipital
Address
1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
Tel
0722523561
k.yanagawa0217@osakah.johas.go.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
| 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
| 2020 | 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
| 2018 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
