UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044902 |
|---|---|
| Receipt number | R000049428 |
| Scientific Title | Effect of Dapagriflozin on renal dysfunction in patients with heart failure |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2021/07/19 15:17:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Dapagriflozin on renal dysfunction in patients with heart failure
Acronym
Effect of Dapagriflozin on renal dysfunction in patients with heart failure
Scientific Title
Effect of Dapagriflozin on renal dysfunction in patients with heart failure
Scientific Title:Acronym
Effect of Dapagriflozin on renal dysfunction in patients with heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Dapagriflozin on renal dysfunction in patients with heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of changes in renal function and renal damage markers at the admission of dapagriflozin, at 2 weeks, and at 2 month
Key secondary outcomes
Relationship between renal function and renal damage markers and 1-year composite endpoint (eGFR decline, end-stage renal failure, heart failure hospitalization, and death)
Changes in QTc dispersion
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic heart failure patients with reduced left ventricular systolic function (EF<50%), no history of heart failure hospitalization within 180 days
Key exclusion criteria
Contraindications in the attached text
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Cardiology
Zip code
101-8643
Address
1 Kandaizumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
yooouyou@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Cardiology
Zip code
101-8643
Address
1 Kandaizumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
yooouyou@gmail.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Mitsui Memorial Hospital
Address
1 Kandaizumicho, Chiyoda-ku, Tokyo
Tel
03-3862-9111
yooouyou@gmail.com
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
| 2021 | Year | 07 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate biomarkers of renal dysfunction and injury after the initiation of SGLT2i
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049428
