UMIN-CTR Clinical Trial

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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