UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015238
Receipt number R000017241
Scientific Title Kyoto Congestive Heart Failure Study
Date of disclosure of the study information 2014/10/01
Last modified on 2020/04/02 14:36:03

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Basic information

Public title

Kyoto Congestive Heart Failure Study

Acronym

KCHF

Scientific Title

Kyoto Congestive Heart Failure Study

Scientific Title:Acronym

KCHF

Region

Japan


Condition

Condition

congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate current status of treatment and long-term outcomes of congestive heart failure patients in Japan

Basic objectives2

Others

Basic objectives -Others

Prospective cohort study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

All-cause death
Composite endpoint of death and hospitalization for heart failure

Key secondary outcomes



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

Patients hospitalized for worsening congestive heart failure

Key exclusion criteria

Patients with :
Acute coronary syndrome
BT on admission over 37.5 degrees C or concomitant of infection
end-stage of renal failure (hemodialysis or serum
Cre over 3.0mg/dL)
Age < 20
Concomitant of severe conditions (terminal of
cancer, end-stage of liver cirrhosis, etc)
difficulty of follow-up

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Kimura

Organization

Kyoto University Hospital

Division name

Cardiovascular medecine

Zip code


Address

54, kawahara-cho, shogoin, sakyo-ku, kyoto

TEL

075-751-4255

Email

taketaka@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Erika Yamamoto

Organization

Kyoto University Hospital

Division name

Cardiovascular medecine

Zip code


Address

54, kawahara-cho, shogoin, sakyo-ku, kyoto

TEL

075-751-4255

Homepage URL


Email

erkymmt@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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


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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 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


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

Main results already published

Date of protocol fixation

2014 Year 09 Month 18 Day

Date of IRB

2014 Year 09 Month 18 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2017 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This prospective cohort study aims to evaluate clinical outcomes of Japanese patients with congestive heart failure.


Management information

Registered date

2014 Year 09 Month 24 Day

Last modified on

2020 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name