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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028668
Receipt No. R000032801
Scientific Title Canagliflozin heart failure with preserved ejection fraction study in type 2 diabetes mellitus
Date of disclosure of the study information 2017/10/01
Last modified on 2019/06/06

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Basic information
Public title Canagliflozin heart failure with preserved ejection fraction study in type 2 diabetes mellitus
Acronym CANONICAL Study
Scientific Title Canagliflozin heart failure with preserved ejection fraction study in type 2 diabetes mellitus
Scientific Title:Acronym CANONICAL Study
Region
Japan

Condition
Condition Heart failure with preserved ejection fraction in type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effects of canagliflozin 100mg administered once a day for 24 weeks on cardiac function using body weight and BNP as indicators in elderly patients with type 2 diabetes mellitus harboring HFpEF with canagliflozin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) The change in BNP at week 24 from the baseline.
2) The change in body weight at week 24 from the baseline.
Key secondary outcomes 1) Hospitalization for heart failure
2) Cardiovascular death / total death
3) The change of body weight at each measurement point from the baseline.
4) The change of dose under loop diuretics.
5) The change in HbA1c from the baseline.
6) The change in BNP and NT-proBNP at each measurement point from the baseline.
7) Echocardiography
8) CONUT score and GNRI
9) FT3, FT4, TSH

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Interventions (The group with Canagliflozin)
The period of intervention: 0-24 weeks.
The dosage of Canagliflozin: 100mg/day.
Interventions/Control_2 Control (The group without Canagliflozin)
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects are the patients who need oral hypoglycemic agents (OHA) even after diet and exercise therapy, and who need additional OHA in other OHA users than SGLT2 inhibitor.

Inclusion criteria
1) Informed consent (IC) from the patient him/herself.
2) >=65 year-old (Female/Male)
3) HbA1c >=6.5%, and HbA1c <10.0% within 8 weeks. HbA1c >=7.0% in case of administration of sulfonylurea, and/or glinide
4) History of heart failure before consent, and echocardiographic mean E/e' >14 (septal E/e' >15, or lateral E/e' >13 ) , or septal e' <7 cm/min, or lateral e' <10 sec/min and LV ejection fraction >=50%, with or without atrial fibrillation (AF)
5) Plasma BNP >=100 pg/mL or plasma NT-proBNP >=400 pg/mL before consent, or plasma BNP >=40 pg/mL or plasma NT-proBNP >=125 pg/mL within 8 weeks before consent, with or without atrial fibrillation (AF)
6) NYHA II or III (<8 weeks from IC)
7) No history of change in drug regimens (<8 weeks from IC)
Key exclusion criteria Exclusion criteria
1) Type 1 DM
2) Treated with GLP-1
3) Patients who need insulin (severe ketosis, diabetic coma or pre-coma, severe infection, peri-operative, severe trauma)
4) Severe renal dysfunction or chronic renal failure during dialysis (In case of moderate renal dysfunction, patients are carefully judged the need for administration of canagliflozin)
5) ACS, CVD, myocarditis, contractile pericarditis, severe HVD (<12 weeks from IC)
6) NYHA IV
7) BMI<18.5kg/ m2
8) The pregnant, breastfeeder
9) Diagnosed or suspected malignant tumors (Patients who did not treat anti-cancer treatment within 1 year before consent can be entered.)
10) Inappropriate patients inappropriate to be included for some reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Saito
Organization Nara Medical University
Division name Department of cardiovascular Medicine
Zip code
Address 840 Shijo, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Email yssaito@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Kasahara
Organization Nara Medical University Hospital
Division name Institute for Clinical and Translational Science
Zip code
Address 840 Shijo, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email kasa@naramed-u.ac.jp

Sponsor
Institute Nara Medical Univercity
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
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
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 日本医科大学武蔵小杉病院(神奈川県)
公立陶生病院(愛知県)
信州大学医学部(長野県)
熊本大学大学院(熊本県)
国立循環器病研究センター(大阪府)
鳥取大学医学部(鳥取県)
兵庫医科大学(兵庫県)
福島県立医科大学(福島県)
平光ハートクリニック(愛知県)
大西ハートクリニック(三重県)
大阪大学大学院(大阪府)
洛和会丸太町病院(京都府)
奈良県西和医療センター(奈良県)
市立奈良病院(奈良県)
南奈良総合医療センター(奈良県)
草津総合病院(滋賀県)
日本心臓血圧研究振興会附属榊原記念病院(東京都)
坂口クリニック(奈良県)
クリニック神宮前(奈良県)
中谷医院(奈良県)
ふじい内科医院(奈良県)
酢谷内科(奈良県)
すぎもと内科クリニック(奈良県)
桐山医院(奈良県)
北海道大学大学院医学研究院(北海道)
群馬大学医学部付属病院(群馬県)
社会福祉法人大阪暁明館 大阪暁明館病院(大阪府)
医療法人新生会 総合病院 高の原中央病院(奈良県)
中山内科・循環器内科クリニック(熊本県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 15 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032801

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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