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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029431
Receipt No. R000033466
Scientific Title Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database -
Date of disclosure of the study information 2017/10/06
Last modified on 2018/11/05

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Basic information
Public title Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database -
Acronym Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database -
Scientific Title Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database -
Scientific Title:Acronym Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database -
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether there are any differences regarding rehospitalization due to HF between patients who had been hospitalized at least twice due to HF and had been administered tolvaptan for a total of at least 30 days (Case 1) or less than 30 days (Case 2) from the day of the hospital discharge (index date) and subjects who had not received tolvaptan (historical control; Hcont and simultaneous control; Scont).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Period until first rehospitalization due to HF after the index date in the Case 1 group and the matched Hcont group and Scont group.
Key secondary outcomes The period until first rehospitalization due to HF after the Index date in the Case 2 group and the matched Hcont group and Scont group. The period until first all cause rehospitalization after the index date in the Case 1 and Case 2 group and respective matched Hcont and Scont group.

Base
Study type Others,meta-analysis etc

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 The patients in the medical facility which obtain the information of in/out patients data continuously least 24 months, were hospitalized least two times during the period from April 1, 2008 through March 31, 2017 due to HF (ICD 10; I11.0, I13.0, I13.2, I50) and were continuously administered any of the diuretics (1st cohort).
Key exclusion criteria Patients who were aged less than 20 years at the time of the Index date
Patients who were not prescribed a diuretic within 30 days after the Index date
Patients who received dialysis (medical treatment of classification No. J038, and J042 by qualified medical personal) within 30 days after the Index date
Patients where the Index date is March 2, 2017 or late
Patients with no NYHA classified data within 1 year before the Index date
Patients who were diagnosed with acute or recurrent myocardial infarction (ICD 10; I2[12]), and unstable angina (ICD 10; I200) within 30 days before the Index date
Patients who were diagnosed with malignant neoplasm (ICD 10; C), liver failure (K704, K72), or an infectious disease with a poor prognosis such as HIV (ICD 10; B2 [01234]) within 1800 days before the Index date.
Patients who were rehospitalized due to HF within 30 days after the Index date
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihito Sato
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Cardiology
Zip code
Address 2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo, Japan
TEL 06-6480-7000
Email cardioys@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Shimamoto
Organization MediStatLab Co., Ltd.
Division name Head Office
Zip code
Address 4-5-11-305 Toyo, Koutou-ku, Tokyo, Japan
TEL 03-6659-7350
Homepage URL
Email skoji@medistatlab.com

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫県立尼崎総合医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 06 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
   A total of 26,181 patients who were hospitalized more than twice because of heart failure (HF) during the period between April 1, 2008, and March 31, 2017, were selected for this study. The patients were divided into Case 1, Case 2, Hcont, and Scont cohorts, each having 719, 1,427, 278, and 6,185, patients, respectively. As the number of patients enrolled in the Hcont cohort was not sufficient to perform analysis, comparison between the Case 1 and Hcont cohorts, which was one of the primary endpoints, was not performed.
   The number of patients who were re-hospitalized because of HF after I date was obviously higher in the Case 1 cohort (402/719) than in the Case 2 (472/1,427) and Scont (1,830/6,185) cohorts.
   Patients in the Case 1 and Scont cohorts were matched using predetermined matching factors. The hazard ratio between the matched Case 1 and Scont cohorts (each with 719 patients) was 1.85 (95% CI 1.57-2.18, p<0.001), indicating a statistically significantly higher risk for re-hospitalization in the Case 1 cohort. This result may have been driven by the limited information on patients in the database, such as the absence of laboratory data and insufficiency of data on the clinical seriousness of HF. Considering the circumstance, tolvaptan was used in the re-hospitalized and critical patients, and it was difficult to adjust the factors to continue this drug, which has a high reimbursement price. As the primary endpoint in this study could not be confirmed to be relevant, we decided to not analyze the secondary endpoints and therefore discontinued the study.
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 Terminated
Date of protocol fixation
2017 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Pharmaco-epidemiological study using DPC data base (EBM Provider; Medical Data Vision Inc., Tokyo, Japan).

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033466

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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