UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061087 |
|---|---|
| Receipt number | R000069899 |
| Scientific Title | Multimodal Data Integration for the Prediction and Prevention of Chronic Heart Failure: A Prospective Cohort Study |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 17:47:18 |
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Basic information
Public title
Multimodal Data Integration for the Prediction and Prevention of Chronic Heart Failure: A Prospective Cohort Study
Acronym
Multimodal Data Integration of Chronic Heart Failure: A Prospective Cohort Study
Scientific Title
Multimodal Data Integration for the Prediction and Prevention of Chronic Heart Failure: A Prospective Cohort Study
Scientific Title:Acronym
Multimodal Data Integration of Chronic Heart Failure: A Prospective Cohort Study
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the associations between genetic variants, imaging findings, histopathological features, and biomarkers in patients with heart failure or those at risk of heart failure, and the onset and progression of heart failure, and to clarify their impact on myocardial vulnerability, treatment responsiveness, and clinical outcomes.
Basic objectives2
Others
Basic objectives -Others
We will evaluate the impact of cardiac remodeling, dynamic changes in biomarkers, exercise capacity, cardiac function, and responsiveness to pharmacological therapy on clinical outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, and hospitalization for unstable angina, heart failure, stroke, or other cardiovascular events, as well as all-cause mortality.
The occurrence of events will be assessed every 12 months after enrollment through review of medical records or patient interviews. The incidence of cardiovascular events will be analyzed using Kaplan-Meier survival curves, and prognostic factors will be identified based on candidate predictors derived from imaging, biomarker, and genetic data.
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 across all heart failure stages, including those at risk for heart failure, those with structural heart disease without heart failure, those with prior or current heart failure, and those with refractory heart failure
Key exclusion criteria
Patients in whom obtaining informed consent for study-related procedures is difficult
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukushima Medical University
Division name
Department of cardiovascular medicine
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima, Fukushima prefecture
TEL
024-547-1190
intmed1@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukushima Medical University
Division name
Department of cardiovascular medicine
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima, Fukushima prefecture
TEL
024-547-1190
Homepage URL
moikawa@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
Fukushima 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
Fukushima Medical University
Address
1-Hikarigaoka, Fukushima, Fukushima prefecture
Tel
024-547-1190
moikawa@fmu.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 | 03 | Month | 27 | 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 | 01 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective cohort study.
Management information
Registered date
| 2026 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069899
