UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045129
Receipt number R000051475
Scientific Title Prognosis survey of patients hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University
Date of disclosure of the study information 2021/08/11
Last modified on 2021/08/11 23:34:29

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Basic information

Public title

Prognosis survey of patients hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University

Acronym

Prognosis survey of patients hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University

Scientific Title

Prognosis survey of patients hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University

Scientific Title:Acronym

Prognosis survey of patients hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University

Region

Japan


Condition

Condition

Patients who were hospitalized for heart failure at the Tokyo Women's Medical University Hospital

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the prognosis of patients who were hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University Hospital.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A composite of cardiovascular death and readmission for heart failure

Key secondary outcomes

All-caused death
Cardiovascular death
In-hospital death
Readmission for heart failure
Implantation of ventricular assist device
Heart transplantation


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were hospitalized for heart failure in the department of cardiology, Tokyo Women's Medical University Hospital

Key exclusion criteria

Patients judged by the principal investigator to be inappropriate as research subjects

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Nobuhisa
Middle name
Last name Hagiwara

Organization

Tokyo Women's Medical University

Division name

Department of Cardiology

Zip code

162-8666

Address

8-1 Kawadacho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

hagiwara.nobuhisa@twmu.ac.jp


Public contact

Name of contact person

1st name Takuma
Middle name
Last name Takada

Organization

Tokyo Women's Medical University

Division name

Department of Cardiology

Zip code

162-8666

Address

8-1 Kawadacho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Homepage URL


Email

takada.takuma@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical review board of Tokyo Women's Medical University

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

Tel

03-3353-8111

Email

krinri.bm@twmu.ac.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

東京女子医科大学病院 (東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 11 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

1930

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 12 Month 09 Day

Date of IRB

2020 Year 12 Month 09 Day

Anticipated trial start date

2020 Year 12 Month 09 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study for patients who were followed up in our institution after the hospitalization for heart failure


Management information

Registered date

2021 Year 08 Month 11 Day

Last modified on

2021 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051475


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name