UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040621 |
|---|---|
| Receipt number | 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 | 2025/12/12 14:19:45 |
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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
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
t.molinaga@gmail.com
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
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
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
1200
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
| 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
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044209
