UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061807 |
|---|---|
| Receipt number | R000070327 |
| Scientific Title | Prospective Registry Study of Comprehensive Clinical Data in Patients Hospitalized for Heart Failure |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/05 12:44:20 |
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Basic information
Public title
Prospective Registry Study of Comprehensive Clinical Data in Patients Hospitalized for Heart Failure
Acronym
A Prospective Observational Study of Prognosis and Treatment Response Using Clinical Data in Patients Hospitalized for Heart Failure
Scientific Title
Prospective Registry Study of Comprehensive Clinical Data in Patients Hospitalized for Heart Failure
Scientific Title:Acronym
ISTAR-HF (Institute of Science Tokyo Hospital Admission Registry for Heart Failure)
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively collect clinical data, laboratory and imaging findings, treatment information, quality-of-life measures, and outcomes in patients hospitalized for heart failure, and to explore prognostic factors, treatment response, and changes in quality of life.
Basic objectives2
Others
Basic objectives -Others
Exploration of prognostic factors, treatment response, and changes in quality of life in patients with heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to the first occurrence of heart failure rehospitalization after discharge, implantable LVAD implantation, or all-cause death from the date of 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
Patients aged 18 years or older who are admitted to the Department of Cardiology, Institute of Science Tokyo Hospital, diagnosed by the attending physician as having AHA/ACC stage C or D heart failure, meet at least one objective criterion including elevated BNP or NT-proBNP, pulmonary congestion or pleural effusion on chest X-ray, or reduced left ventricular ejection fraction or diastolic dysfunction on echocardiography, and provide written informed consent personally or through a legally acceptable representative.
Key exclusion criteria
Patients whose primary condition is judged to be a disease other than heart failure, those with an end-stage condition with an expected prognosis of only several weeks, those who cannot understand participation in the study and have no legally acceptable representative, patients on chronic dialysis, and patients after heart transplantation.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isotani |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
isotani.yoshitaka@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isotani |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
isotani.yoshitaka@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Ethics Review Committee, Institute of Science Tokyo
Address
Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 05 | 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
| 2026 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study using clinical information obtained during routine care. No additional tests, treatments, or procedures will be performed for research purposes.
Management information
Registered date
| 2026 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070327
