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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046107
Receipt No. 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 2021/11/18

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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
Email 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
Email Matsukawa.Miyuki@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052634

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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