UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure
Title of the study (Brief title)	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	Hidekazu Tanaka
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-5846
Email	tanakah@med.kobe-u.ac.jp

Public contact
Name of contact person	Hidekazu Tanaka
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-5846
Homepage URL
Email	tanakah@med.kobe-u.ac.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30296931
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022859