UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019789 |
|---|---|
| Receipt number | R000022859 |
| Scientific Title | Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2018/11/16 11:22:59 |
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Basic information
Public title
Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure
Acronym
Effect of Dapagliflozin on left ventricular diastolic function
Scientific Title
Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure
Scientific Title:Acronym
Effect of Dapagliflozin on left ventricular diastolic function
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with chronic heart failure
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of of dapagliflozin on left ventricular diastolic function by means of echocardiography and BNP in type 2 diabetic patients with chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular diastolic function by means of echocardiography after 6- and 12-month after administration of dapagliflozin (E/A, E/E', left atrial volume index and left ventricular mass index)
Key secondary outcomes
BNP after 6- and 12-month after administration of dapagliflozin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 5mg or 10mg dapagliflozin once a day, post breakfast
Interventions/Control_2
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) 20 years and older and 75 years and yonger (male and female)
2) Is diagnosed with type 2 diabetes and the investigator considered that addition of dapagliflozin is possible
3) Is diagnosed with HbA1c 6.0-10.0%
4) Is diagnosed with chronic heart failure (NYHA class is I-III)
5) NYHA functional classification dosn't change in 4 weeks prior to eligibility qualification and dose of heart failure treatment drugs (such as ACE inhibitor, ARB, beta blocker, diuretic etc.) dosn't change
6) The patient provided written informed consent to participate in the study
Key exclusion criteria
1) Tpe 1 diabetis
2) Blood pressure of <90/50 mmHg
3) Has history of heart failure, acute coronary syndrome, cerebrovascular disease, myocarditis, constrictive pericarditis, or severe valvular disease within 4 months
4) Has history of uncontrolled atrial fibrillation or flutter within 1 month.
5) Has history of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack within 6 months
6) Current use of insuline
7) With severe renal dysfunction (eGRF < 45 mL/min/1.73m 2 or patient undergoing artificial dialysis)
8) Has malignancy
9) With serious liver disfunction (AST or ALT is 3 times site reference value or more)
10) With pituitary gland dysfunction or adrenal gland dysfunction
11) With malnutrition, starvation, irregular eating pattern, lack of dietary intake, debilitaion
12) Pregnant, possibly pregnant, planned to become pregmant or nursing women
13) Has history of hypersensitivity to dapagliflozin, glimepiride or sulfonamides
14) Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5846
tanakah@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5846
Homepage URL
tanakah@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学病院（兵庫県）
神戸赤十字病院（兵庫県）
大阪府済生会中津病院（大阪府）
愛仁会高槻病院（大阪府）
辰巳医院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30296931
Number of participants that the trial has enrolled
Results
Primary end point
E/e showed significant decrease from 9.3 cm/s (7.7-11.8) to 8.5 cm/s (6.6-10.7) (p=0.020) 6 months after administration of dapagliflozin.
Secondary end point
LAVI and LVMI showed significant decreases from 31 mL/m2 (23-45) to 26 mL/m2 (21-32) (p=0.001), and from 75.0 g/m2 (61.7-92.0) to 67.0 g/m2 (55.0-81.9) (p<0.001) 6 months after administration of dapagliflozin, respectively. No significant change was observed in BNP 6 months after administration of dapagliflozin from 27.9 pg/mL (9.0-58.2) at baseline to 28.9 pg/mL (9.6-62.9) (p=0.132), but BNP significantly decreased from 168.8 pg/mL (144.3-465.3) to 114.3 pg/mL (98.3-235.3) (p = 0.012) in T2DM patients with BNP>100 pg/mL.
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
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 14 | Day |
Last modified on
| 2018 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022859
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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