UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041519
Receipt number R000047401
Scientific Title A retrospective observational study of prognostic factors for acute heart failure
Date of disclosure of the study information 2020/08/31
Last modified on 2020/10/22 09:21:34

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Basic information

Public title

A retrospective observational study of prognostic factors for acute heart failure

Acronym

Kokura CHF Registry 2015

Scientific Title

A retrospective observational study of prognostic factors for acute heart failure

Scientific Title:Acronym

Kokura CHF Registry 2015

Region

Japan


Condition

Condition

congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the current status of treatment and clinical outcomes and to survey the prognostic factors in patients with congestive heart failure.

Basic objectives2

Others

Basic objectives -Others

retrospective cohort study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

all-cause death, and rehospitalization for heart failure

Key secondary outcomes

cardiac death, bleeding event, ischemic event, arrhythmia event, renal failure event


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 hospitalized for worsening congestive heart failure

Key exclusion criteria

Age < 18

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Isotani
Middle name
Last name Akihiro

Organization

Kokura memorial hospital

Division name

cardiology

Zip code

8028555

Address

Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi

TEL

093-511-2000

Email

isotani1978@gmail.com


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Kanenawa

Organization

Kokura memorial hospital

Division name

cardiology

Zip code

8028555

Address

Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi

TEL

093-511-2000

Homepage URL


Email

kanesannsann@yahoo.co.jp


Sponsor or person

Institute

Kokura memorial hospital

Institute

Department

Personal name



Funding Source

Organization

Not applicable

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

linical research center,Kokura Memorial Hospital

Address

3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,

Tel

0935112000

Email

crc@kokurakinen.or.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

2020 Year 08 Month 31 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

600

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

2018 Year 12 Month 06 Day

Date of IRB

2019 Year 02 Month 12 Day

Anticipated trial start date

2019 Year 02 Month 15 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective cohort study


Management information

Registered date

2020 Year 08 Month 23 Day

Last modified on

2020 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047401


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name