UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058467 |
|---|---|
| Receipt number | R000066851 |
| Scientific Title | Retrospective Analysis of Prognostic Factors Including Pharmacotherapy, Echocardiographic Parameters, Nutritional Status, Frailty, and Underlying Cardiac Disease in Patients With Heart Failure |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/14 20:38:31 |
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Basic information
Public title
A retrospective study in patients with heart failure
Acronym
Research on heart failure
Scientific Title
Retrospective Analysis of Prognostic Factors Including Pharmacotherapy, Echocardiographic Parameters, Nutritional Status, Frailty, and Underlying Cardiac Disease in Patients With Heart Failure
Scientific Title:Acronym
PREDICTive factors in Heart Failure Study
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify prognostic factors affecting long-term outcomes in patients with heart failure by utilizing multidimensional clinical data, including pharmacotherapy, echocardiographic findings, nutritional status, frailty, and underlying cardiac diseases, in order to achieve more accurate prediction of prognosis and risk stratification.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
Heart failure rehospitalization
Composite outcome of all-cause mortality and heart failure rehospitalization
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hospitalized patients with heart failure
Key exclusion criteria
Although this study utilized an opt-out consent process, if a patient or their family specifically requested withdrawal of consent during hospitalization, the patient was excluded from the study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura Memorial Hospital
Division name
department of cardiology
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
093-511-2000
kanesannsann@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miyamoto |
Organization
Kokura Memorial Hospital
Division name
department of cardiology
Zip code
802-8555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
093-511-2000
Homepage URL
k.miyamoto1229@gmail.com
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
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 Clinical Research Review Committee
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
Tel
093-511-2000
rinsyorinsyo@kokurakinen01.onmicrosoft.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
| 2025 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
2800
Results
Of the patients discharged after heart failure hospitalization, 27% experienced a mortality event within two years.
Results date posted
| 2025 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient characteristics were as follows: the mean age was 80 years, and 40% of the patients were male.
Participant flow
A total of 2,800 patients were included in this study.
Adverse events
nothing
Outcome measures
Of the patients discharged after heart failure hospitalization, 27% experienced a mortality event within two years.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066851
