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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035243
Receipt No. R000039844
Scientific Title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Heart Failure
Date of disclosure of the study information 2019/01/04
Last modified on 2018/12/13

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Basic information
Public title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Heart Failure
Acronym Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Heart Failure (EXPLORE-HF)
Scientific Title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Heart Failure
Scientific Title:Acronym Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Heart Failure (EXPLORE-HF)
Region
Japan

Condition
Condition Type2 Diabetes
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Targeting type 2 diabetes patients, the standard treatment of diabetes mellitus (no use of sodium glucose transporter 2 (SGLT2) inhibitors nor insulin injection) and a SGLT2 inhibitor treatment will be compared to discuss the mechanism of the drug to restore cardiomyocyte energy metabolism in heart failure in terms of keton metabolism, along with blood test and imaging test data.
Basic objectives2 Others
Basic objectives -Others Exploratory study of Luseogliflozin, one of SGLT2 inhibitors, for its mechanism to restore cardiomyocyte energy metabolism.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in the quantity and rate of keton absorbed by cardiac muscles in the second week of treatment.
Key secondary outcomes 1) Improvement in cardiac function in the second week and 6th month of treatment:brain natriuretic peptide (BNP), left ventricular diastolic performance (E/e'), and ejection fraction (EF).

2)Change in Hemoglobin A1c(HbA1c) and blood glucose level from the base line (zero week of treatment).

3)Change in BNP (and N-terminal pro-brain natriuretic peptide(NT-proBNP)from the base line (zero week of treatment).

4)Echocardiographic evaluation:E/e',LV mass index, EF, LA volume index.

5)Change in glycometabolism and fatty acid metabolism ove the two weeks of treatment.

6)Change in keton concentration over the two weeks of treatment and its relation to ALDH2 gene polymorphism.

7)Change in vascular endothelial function over the two weeks of treatment.

8)Hemodynamic status by right heart catheter over the two weeks of treatment.

9)Change in troponin T level over the two weeks of treatment.

10)Change in holter electrocardiogram over the two weeks of treatment.

11)Change in renal function over the six months of treatment.


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The standard treatment (no use of SGLT2 inhibitors nor insulin injection)will be continued and observed for the predefined items for six months at maximum.
Interventions/Control_2 2.5mg of Luseogliflozin will be given daily in the morning and observed for the predefined items for six months at maximum.
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

Not applicable
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients who fulfill the following conditions;
1)Signed informed consent to join the study.
2)HbA1c level on the day of the consent signature is no less than 6.0% and no more than 12.0%.
3)Up to the day of the signature, have a history of heart failure, and ecocardiography taken within one year shows EF of no more than 55% or E/e' of no less than 15, with or without atrial fibrillation (AF).
4)WIthin 8 weeks up to the day of the signature, BNP level is no less than 40pg/mL or NT-proBNP is no less than 150pg/mL.
5)Within 8 weeks up to the day of the signature, the severity of heart failure is judged II to III according to the categorization by New York Heart Association (NYHA).
6)Cardiac catheterization is required to evaluate cardiac function and coronary artery condition.
Key exclusion criteria Any person who
1)Has type I diabetes.
2)Requires insulin for blood glucose control (including the conditions such as severe ketosis, diabetic coma or precoma, severe infectious disease, perioperative period, or severe trauma).
3)Had severe renal dysfunction (estimated glomerular filtration rate (eGFR) is less than 45mL/min/1.73m2 or dialysis is required).
4)Has severe hepatic dysfunciton.
5)Has a history of the following disorders within 12 weeks up to the day of the signature;acute coronary syndromes, cerebrovascular disorder, myocarditis, pericarditis constrictiva, or severe valvular disorder.
6)Has heart failure of severity IV according to the categorization by New York Heart Association (NYHA).
7)Body mass index (BMI) is less than 18.5kg/m2 or at malnutrition or starvation state.
8)Has a history of intolerance to the target drug.
9)Is pregnant, breast-feeding, or likely pregnant.
10)Is diagnosed of malignant tumor or so suspected.
11)Is a the age of 85 or older.
12)Is judged inappropriate for the study by the investigators.
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuji Mizuno
Organization Medical Corporataion Juryo
Kumamoto Kinoh Hospital
Division name Cardiovascular internal medicine
Zip code
Address 6-8-1 Yamamuro Kita-ku, Kumamoto
TEL 096-345-8111ext.3057
Email mizuno@juryo.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuji Mizuno
Organization Medical Corporataion Juryo Kumamoto Kinoh Hospital
Division name Cardiovascular internal medicine
Zip code
Address 6-8-1 Yamamuro Kita-ku, Kumamoto
TEL 096-345-8111ext.3057
Homepage URL
Email mizuno@juryo.or.jp

Sponsor
Institute Cardiovascular internal medicine

Medical Corporataion Juryo
Kumamoto Kinoh Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 11 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 13 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039844

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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