UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046107 |
|---|---|
| Receipt number | R000052634 |
| Scientific Title | Impact of diuretics use in long-term management of congestive heart failure patients to prevent re-hospitalization using the Diagnosis Procedure Combination Database |
| Date of disclosure of the study information | 2021/11/20 |
| Last modified on | 2022/06/07 09:51:08 |
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Basic information
Public title
Impact of diuretics use in long-term management of congestive heart failure patients to prevent re-hospitalization using the Diagnosis Procedure Combination Database
Acronym
Impact of diuretics use in long-term management of congestive heart failure patients to prevent re-hospitalization using the Diagnosis Procedure Combination Database
Scientific Title
Impact of diuretics use in long-term management of congestive heart failure patients to prevent re-hospitalization using the Diagnosis Procedure Combination Database
Scientific Title:Acronym
Impact of diuretics use in long-term management of congestive heart failure patients to prevent re-hospitalization using the Diagnosis Procedure Combination Database
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors affecting re-hospitalization for heart failure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of readmissions due to HF and time to readmission during the second post-discharge follow-up period (after 1 year)
Key secondary outcomes
In-hospital death
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have two or more hospitalizations for the target disease within the inclusion period.
2. Patients who were prescribed the target drug during the above hospitalization and who were continuously prescribed the target drug after discharge from the hospital.
3. Any medical intervention has been performed at least once after the second discharge.
Key exclusion criteria
1.Patients younger than 20 years at the time of the second hospitalization for the disease of interest
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL
080-6791-7646
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
540-0021
Address
3-2-27, Otedori, Chuo-ku, Osaka-shi, Osaka 540-0021, Japan
TEL
080-6791-7646
Homepage URL
Matsukawa.Miyuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department
Personal name
Funding Source
Organization
None
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
RIHDS Ethics Review Board
Address
2-5-5 Shibadaimon, Minato-ku, Tokyo Sumitomo Shibadaimon Building 12th floor, inside JMDC Co., Ltd.
Tel
03-5733-5010
rihds@jmdc.co.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 | 11 | Month | 20 | 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
11257
Results
In this study, compared to loop diuretics, additional tolvaptan treatment was not shown to be effective for the time to readmission due to heart failure. Re-hospitalization for heart failure has been shown to be associated with age, Na, creatinine, and prescriptions of ACE inhibitors or ARBs and thiazides. On the other hand, additional treatment with tolvaptan was shown to be significantly longer in terms of time to in-hospital death.
Results date posted
| 2022 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(Cohort)
Tolvaptan male 57.4%
Furosemide male 53.2%
Tolvaptan age 78.0(years)
Furosemide age 78.5(years)
Participant flow
N/A
Adverse events
N/A
Outcome measures
Heart failure hospitalization
In-hospital death
Plan to share IPD
No
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 25 | Day |
Other
Other related information
Examination of the relationship between diuretic administration and readmission and in-hospital death due to heart failure.
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052634
