UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032169 |
|---|---|
| Receipt number | R000036691 |
| Scientific Title | Observational study on acutely decompensated heart failure |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2025/10/14 09:19:59 |
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Basic information
Public title
Observational study on acutely decompensated heart failure
Acronym
A prospective multicenter registry (West Tokyo Heart Failure 2: WET-HF2)
Scientific Title
Observational study on acutely decompensated heart failure
Scientific Title:Acronym
A prospective multicenter registry (West Tokyo Heart Failure 2: WET-HF2)
Region
| Japan |
Condition
Condition
acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical presentation, applied treatment and prognosis of patients with acute decompensated heart failure in Japan, in internationally validated platform.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital and long-term (2-5 years) outcomes after index hospitalization.
Key secondary outcomes
Annual changes in left ventricular ejection fraction, natriuretic peptide levels, renal function, and exercise tolerance
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
Key exclusion criteria
Acute coronary syndrome
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Kohsaka |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
sk@keio.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Shiraishi |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
yasshiraishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Research Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
杏林大学病院（東京都）
榊原記念病院（東京都）
防衛大学校病院（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
独立病院機構東京医療センター（東京都）
東京都済生会中央病院（東京都）
聖路加国際病院（東京都）
東邦大学大森病院（東京都）
昭和大学病院（東京都）
東京医科大学病院（東京都）
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ahajournals.org/doi/10.1161/JAHA.123.031179?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036691
