UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058112 |
|---|---|
| Receipt number | R000066417 |
| Scientific Title | Acquisition of real-world data on current clinical assessment, medical therapy and prognosis in heart failure |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/07 10:53:48 |
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Basic information
Public title
Acquisition of real-world data on current clinical assessment, medical therapy and prognosis in heart failure
Acronym
QUALITY-HF
Scientific Title
Acquisition of real-world data on current clinical assessment, medical therapy and prognosis in heart failure
Scientific Title:Acronym
QUALITY-HF
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the latest and most detailed clinical characteristics, actual medical practices, pathophysiology, and prognosis of patients hospitalized with heart failure, in order to improve the quality of heart failure care and the accuracy of prognosis prediction.
Basic objectives2
Others
Basic objectives -Others
Information will be collected on patients' symptoms,physical findings, clinical laboratory data, treatment data, disease phenotypes based on blood protein expression, and patients' quality of life and understanding of their condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint of death 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients who are diagnosed with heart failure based on the Modified Framingham criteria and require hospitalization for heart failure treatment with injectable medications
2 Patients who are 18 years of age or older at the time of consent and/or enrollment.
Key exclusion criteria
1 Patients with acute coronary syndrome requiring urgent revascularization within 24 hours of admission
2 Patients undergoing maintenance dialysis
3 Patients who reside overseas or are expected to relocate overseas, making follow-up difficult
4 Any other patients deemed unsuitable for participation in the study by the principal investigator or co-investigators
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Koh |
| Middle name | |
| Last name | Ono |
Organization
Kyoto University hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
0757514255
kohono@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Nagao |
Organization
Kyoto University hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
0757514255
Homepage URL
nagao@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine Kyoto University Hospital
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 10 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective cohort study
Management information
Registered date
| 2025 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066417
