UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039340 |
|---|---|
| Receipt number | R000044868 |
| Scientific Title | Efficacy and safety of combination therapy with vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure: A randomized controled trial |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/05/07 13:07:00 |
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Basic information
Public title
Efficacy and safety of combination therapy with tolvaptan and dapagliflozin in patients with acute decompensated heart failure: A randomized controled trial
Acronym
Combination therapy of tolvaptan and dapagliflozin in patients with acute decompensated heart failure
Scientific Title
Efficacy and safety of combination therapy with vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure: A randomized controled trial
Scientific Title:Acronym
Combination therapy of vasopressin type-2 antagonist and SGLT2 inhibitor in patients with acute decompensated heart failure
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of combination therapy with tolvaptan and dapagliflozin in acute decompensated heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of 72 hours total urine output between tolvaptan alone therapy vs. combination therapy with tolvaptan and dapagliflozin
Key secondary outcomes
Akute kidney injury during hospitalization
Dose of furosemide at discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan alone therapy
Interventions/Control_2
Combination therapy with tolvaptan and dapagliflozin
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
At admission by Acute decompansated heart failure
Patients with diabetes mellitus
Patients without tolvaptan and SGLT2 inhibitor administration
Patients with preserved renal function (eGFR > 30)
Key exclusion criteria
Patients with acute coronary syndrome
Patients with out-of-hospital cardiac arrest
No tolerability of tolvaptan or dapagliflozin
Rejected study enrollment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi
TEL
81669921001
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Bando |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
5708507
Address
10-15, Fumizono-cho, Moriguchi
TEL
0669921001
Homepage URL
bandoshi@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center
Address
10-15, Fumizono-cho, Moriguchi
Tel
0669921001
bandoshi@takii.kmu.ac.jp
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
| 2020 | Year | 01 | Month | 31 | 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
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044868
