UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057950 |
|---|---|
| Receipt number | R000066252 |
| Scientific Title | Study and Investigation by MuLtiCenteR Observational Registry for Acute Decompensated Heart Failure: SILCROAD-HF |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/23 18:53:03 |
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Basic information
Public title
Study and Investigation by MuLtiCenteR Observational Registry for Acute Decompensated Heart Failure: SILCROAD-HF
Acronym
SILCROAD-HF
Scientific Title
Study and Investigation by MuLtiCenteR Observational Registry for Acute Decompensated Heart Failure: SILCROAD-HF
Scientific Title:Acronym
SILCROAD-HF
Region
| Japan |
Condition
Condition
Acute Decompensated Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively analyze patients hospitalized with acute heart failure
Basic objectives2
Others
Basic objectives -Others
To clarify the pathology of heart failure and prognostic predictors by comprehensively analyzing patient background factors, pathological evaluation items, and prognostic information in patients with heart failure, and to discover knowledge that will lead to the development of new diagnostic and therapeutic methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival from registration
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NT-proBNP 300 pg/ml or BNP 100 pg/ml or more at the time of admission. If atrial fibrillation is present at the time of admission, NT-proBNP 900 pg/ml or BNP 300 pg/ml or more
Written informed consent to participate in the study can be obtained
Key exclusion criteria
Patients under 18 years of age
Patients with acute coronary syndrome or acute pulmonary embolism at the time of admission
Patients with extracardiac disease diagnosed with a prognosis of less than six months
Maintenance dialysis patients
Other patients deemed inappropriate by the attending physician
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Shungo |
| Middle name | |
| Last name | Hikoso |
Organization
Nara Medical University
Division name
Department of cardiovascular medicine
Zip code
634-0813
Address
Shijo-cho 840, Kashihara, Nara
TEL
0744-22-3051
hikoso@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuki |
| Middle name | |
| Last name | Nakada |
Organization
Nara Medical University
Division name
Department of cardiovascular medicine
Zip code
634-0813
Address
Shijo-cho 840, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
ynakada@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
Shijo-cho 840, Kashihara, Nara
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
奈良県立医科大学附属病院（奈良県）、済生会吹田病院（大阪府）、市立奈良病院（奈良県）、奈良県西和医療センター（奈良県）、奈良県総合医療センター（奈良県）、南奈良総合医療センター（奈良県）、大和橿原病院（奈良県）、大和高田市立病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2025 | 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
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cohort study using a prospective registry. Patients who have been admitted to the relevant facilities since the start of registration and who meet the inclusion criteria and do not violate the exclusion criteria will be enrolled. After discharge, information mainly on prognosis will be collected annually, and patients will be followed up for up to five years from the start of registration.
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066252
