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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040621
Receipt No. R000044209
Scientific Title Kokura Prospective Investigation to Check up on True Outcome of Patients with Congestive Heart Failure
Date of disclosure of the study information 2020/06/02
Last modified on 2020/06/02

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Basic information
Public title Kokura Prospective Investigation to Check up on True Outcome of Patients with Congestive Heart Failure
Acronym KNOCK-OUT HF
Scientific Title Kokura Prospective Investigation to Check up on True Outcome of Patients with Congestive Heart Failure
Scientific Title:Acronym KNOCK-OUT HF
Region
Japan

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

Objectives
Narrative objectives1 To evaluate clinical baseline characteristics and outcomes of Japanese patients with congestive heart failure
Basic objectives2 Others
Basic objectives -Others Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Cardiac death
2)Non-cardiac death
3)Re-hospitalization for heart failure
4)All-cause re-hospitalization
Key secondary outcomes 1)Comparison of outcome in patients with HFrEF, HFmrEF and HFrEF
2)relationship between stroke volume and adverse event
3)relationship between atrial fibrillation and heart failure
4)Estimation of reverse remodeling
5)relationship between cadiorenal syndrome and heart failure
6)relationship between addition of medicine in discharge and outcome
7)relationship between heart rate and outcome
8)relationship between frailty and outcome

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 unplanned hospitalization for acute decompensated heart failure with any therapy
Key exclusion criteria 1)hospitalization for examination
2)patients who hospitalize in any department other than cardiology
3)patients who reject participation in research
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Ando
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code 8028555
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu
TEL 0935112000
Email kenji-ando@live.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Morinaga
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code 8020001
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu
TEL 0935112000
Homepage URL
Email t.molinaga@gmail.com

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization none
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 Kokura Memorial Hospital
Address 3-2-1 Asano, Kokurakita-ku
Tel 0935112000
Email t.molinaga@gmail.com

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 06 Month 02 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 05 Day
Date of IRB
2019 Year 02 Month 18 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2029 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 06 Month 02 Day
Last modified on
2020 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044209

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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