UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060518 |
|---|---|
| Receipt number | R000068702 |
| Scientific Title | Patient-Reported Outcome in Clinical practicE for Symptomatic-Stage Heart Failure registry |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/30 11:29:02 |
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Basic information
Public title
Patient-Reported Outcome in Clinical practicE for Symptomatic-Stage Heart Failure registry
Acronym
PROCESS-HF registry
Scientific Title
Patient-Reported Outcome in Clinical practicE for Symptomatic-Stage Heart Failure registry
Scientific Title:Acronym
PROCESS-HF registry
Region
| Japan |
Condition
Condition
Symptomatic heart failure patients who are initially hospitalized
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the cross-sectional and longitudinal association between patient background and indicators such as echocardiograms, cardiac MRI scans, and cardiac catheterization tests and each evaluation index of the KCCQ. In addition, to assess the association with subsequent hard outcomes by prospectively following up registered patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KCCQ-12 score
Key secondary outcomes
KCCQ-12 each domain score
Changes in KCCQ-12 scores over time from baseline
Death, hospitalization for heart failure, and worsening of heart failure (increased diuretic dose in outpatient clinics)
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 who presented with symptomatic first-time heart failure
Key exclusion criteria
Patients who were not able to give consent
Younger than 20 years old
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ejiri |
Organization
Okayama University Hospital
Division name
Cardiovascular Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-Ku, Okayama
TEL
0862357351
kejiri1@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ejiri |
Organization
Okayama University Hospital
Division name
Cardiovascular Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-Ku, Okayama
TEL
0862357351
Homepage URL
kejiri1@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital Ethics Commitee
Address
2-5-1 Shikata-cho, Kita-Ku, Okayama
Tel
0862356938
mae6605@adm.okayama-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
岡山大学病院（岡山県）
岡山市立岡山市民病院（岡山県）
津山中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | 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 | 10 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of this study will be presented at relevant academic conferences and published as a paper in a specialized academic journal in the cardiovascular field. In either case, only statistically processed results will be published.
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068702
