UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039975 |
|---|---|
| Receipt number | R000045578 |
| Scientific Title | Consortium for pooled data analysis regarding hospitalized patients with heart failure in Japan |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/03/30 10:33:25 |
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Basic information
Public title
Consortium for pooled data analysis regarding hospitalized patients with heart failure in Japan
Acronym
COOPERATE-HF-J
Scientific Title
Consortium for pooled data analysis regarding hospitalized patients with heart failure in Japan
Scientific Title:Acronym
COOPERATE-HF-J
Region
| Japan |
Condition
Condition
Acute Heart Failure Syndrome
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current state of treatment for acute heart failure syndrome (AHFS) including in the emergency department (ED) and it's effect on prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Combined endpoint of all-cause mortality and readmission due to heart failure within 1 year.
Key secondary outcomes
In-hospital death; all-cause mortality within 30 days/90 days/1 year after discharge; heart failure readmission rate within 30 days/90 days/1 year after discharge.
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 required for urgent care of acutely decompensated heart failure who are diagnosed according to Framingham criteria.
Key exclusion criteria
(1) Patients without consent
(2)
NARA-HF
1. Acute coronary syndrome
2. Acute myocarditis
3. Acute right heart failure with acute pulmonary embolism
REALITY-AHF
1. After cardiac transplantation
2. Chronic hemodialysis
3. Acute myocarditis
4. Acute coronary syndrome require emergent revascularization
WET-HF
1. Acute coronary syndrome
MEIDAI-HF
1. Patients judged by the attending physician or the investigator to be inappropriate
Target sample size
8500
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
yuya8950@gmail.com
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Nogi |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
nogi18kazu@naramed-u.ac.jp
Sponsor or person
Institute
COOPERATE-HF-J
Institute
Department
Personal name
Funding Source
Organization
none
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
Nara Medical University Research Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
奈良県立医科大学（奈良）・亀田メディカルセンター（千葉）・慶應義塾大学（東京）・名古屋大学（愛知）・神戸市立医療センター中央市民病院（兵庫）・聖路加国際病院（東京）・聖マリアンナ医科大学（神奈川)・北里大学（神奈川）・東京医科大学茨城医療センター（茨城）・東京医科歯科大学（東京）・福島県立医科大学（福島）・筑波大学（茨城）・横浜市立大学附属市民総合医療センター（神奈川）・日本医科大学（東京）・日本医科大学武蔵小杉病院（神奈川）・心臓病センター榊原病院（岡山）・兵庫県立姫路循環器病センター（兵庫）・神戸百年記念病院（兵庫）・武蔵野赤十字病院（東京）・済生会福岡総合病院（福岡）・高知大学（高知）・滋賀県立成人病センター（滋賀）・赤穂市民病院（兵庫）・榊原記念病院（東京）・杏林大学（東京）・東京都済生会中央病院（東京）・国立病院機構東京医療センター（東京）・埼玉医科大学国際医療センター（埼玉）・防衛医科大学（埼玉）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Elucidate the correlation between therapy for AHFS in the acute phase and prognosis by prospective multicenter registry in Japan.
Management information
Registered date
| 2020 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045578
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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