UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052634