UMIN-CTR Clinical Trial

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
Email	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
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	Osaka Rosai Hosipital
Address	1179-3 Nagasone-cho, Kita-ku, Sakai-City, Osaka
Tel	0722523561
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035848