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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | congestive heart failure | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 1500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | none |
Management information | |||||||
Registered date |
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Last modified on |
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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 |