UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000029431
Receipt number	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 10:58:51

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Heart Failure

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

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 or person

Institute

Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033466