UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044342 |
|---|---|
| Receipt number | R000050643 |
| Scientific Title | ROAD-AHF |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2023/06/02 13:41:14 |
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Basic information
Public title
Reduction of worsening renal function by adding dapagliflozin to manage acute heart failure
Acronym
ROAD-AHF
Scientific Title
ROAD-AHF
Scientific Title:Acronym
ROAD-AHF
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of dapagliflozin for patients with acute heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of worsening renal function
Key secondary outcomes
amounts 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
Dapagliflozin
10mg
during hospitalization
Interventions/Control_2
conventional therapy
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
Patients with acute heart failure.
at least one physical examination, edema or jugular vein distension
Key exclusion criteria
use of inotropic agents
mechanical support
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | masami |
| Middle name | |
| Last name | nishino |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
mnishino@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Shodai |
| Middle name | |
| Last name | Kawanami |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
Homepage URL
junnai-hisho@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Rosai Hospital
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
Osaka Rosai Hospital
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel
072-252-3561
junnai-hisho@osakah.johas.go.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
| 2021 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050643
