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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029436
Receipt No. R000033630
Scientific Title Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study
Date of disclosure of the study information 2017/10/20
Last modified on 2018/09/05

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Basic information
Public title Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study
Acronym KCHF Long-term follow-up
Scientific Title Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study
Scientific Title:Acronym KCHF Long-term follow-up
Region
Japan

Condition
Condition congestive heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate long-term outcomes of all patients enrolled in KCHF study
Basic objectives2 Others
Basic objectives -Others Retrospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause death (one year from enrollment)
Key secondary outcomes Death from heart failure, sudden cardiac death, non-cardiac death, re-hospitalization, re-hospitalization for heart failure, arrhythmia, stroke, cardiac surgery, severe bleeding, adverse drug events

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 enrolled in KCHF study (patients who
need specific intravenous heart failure treatment within 24 hours from presentation) and discharged from hospitals
Key exclusion criteria NO consent
Target sample size 3794

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 kawahara-cho, Sakyouku, Kyoto
TEL 0757514255
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Kato
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Kawahara-cho, Sakyou-ku, Kyoto
TEL 0757514255
Homepage URL
Email tkato75@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University
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 京都大学病院(京都府)、天理よろづ相談所病院(奈良県)、国立病院機構 京都医療センター(京都府)、三菱京都病院(京都府)、心臓病センター医療法人親友会 島原病院(京都府)、大津赤十字病院(滋賀県)、滋賀県立成人病センター(滋賀県)、彦根市立病院(滋賀県)、大阪赤十字病院(大阪府)、財団法人 田附興風会 医学研究所 北野病院(大阪府)、市立岸和田市民病院(大阪府)、関西電力病院(大阪府)、兵庫県立尼崎総合医療センター(兵庫県)、日本赤十字社和歌山医療センター(和歌山県)、静岡県立総合病院(静岡県)、神戸市立医療センター中央市民病院(兵庫県)、倉敷中央病院(岡山県)、小倉記念病院(福岡県)、京都岡本記念病院(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 20 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 08 Month 01 Day
Date analysis concluded

Other
Other related information This study aims to evaluate the long-term outcomes of patients enrolled KCHF registry.

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033630

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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