UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063174 |
|---|---|
| Receipt number | R000072300 |
| Scientific Title | Retrospective and prospective observational studies of patients with heart failure |
| Date of disclosure of the study information | 2026/10/10 |
| Last modified on | 2026/10/09 13:06:24 |
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Basic information
Public title
Retrospective and prospective observational studies of patients with heart failure
Acronym
Retrospective and prospective observational studies of patients with heart failure
Scientific Title
Retrospective and prospective observational studies of patients with heart failure
Scientific Title:Acronym
Retrospective and prospective observational studies of patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are currently facing a "heart failure pandemic," with a rising number of patients worldwide presenting a significant challenge. At the same time, this field is witnessing remarkable progress in the development of novel pharmacological agents and invasive therapies. Global research is ongoing to determine which treatments effectively reduce mortality and heart failure readmission rates. The objective of this study is to further investigate the factors influencing mortality and survival outcomes, thereby striving to provide superior medical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death, heart failure readmission
Key secondary outcomes
Cardiovascular death, non-cardiovascular death, acute kidney injury, dialysis, complications, and adverse effects,UPCR/UACR
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient hospitalized for heart failure
Key exclusion criteria
A patient who indicated an intention to refuse participation in the study.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura memorial hospital
Division name
Cardiology
Zip code
8020001
Address
3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
TEL
0935112000
kanesannsann@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura memorial hospital
Division name
Cardiology
Zip code
8020001
Address
Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL
0935112000
Homepage URL
kanesannsann@yahoo.co.jp
Sponsor or person
Institute
Kokura memorial hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical research center,Kokura Memorial Hospital
Address
3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
Tel
0935112000
rinsyo@kokurakinen.or.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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2030 | 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 single-center retrospective and prospective observational study of patients with heart failure. The study will comprehensively evaluate the associations of heart failure phenotype and severity, comorbidities, pharmacological and non-pharmacological therapies, hemodynamic status, renal function, and congestion with clinical outcomes.
Particular attention will be paid to cardiorenal interactions in heart failure. In addition to conventional renal function parameters, including serum creatinine and estimated glomerular filtration rate (eGFR), urinary findings such as the urine protein-to-creatinine ratio (UPCR), urine albumin-to-creatinine ratio (UACR), and urinary sediment will be evaluated. The presence and severity of proteinuria and albuminuria will be examined in relation to heart failure severity, congestion, comorbidities, treatment patterns, and subsequent clinical outcomes.
The associations of contemporary heart failure therapies, renoprotective and cardiorenal protective therapies, diuretic therapy, and invasive treatments with clinical outcomes will also be investigated in routine clinical practice. Major clinical outcomes include in-hospital mortality and heart failure rehospitalization. Cardiovascular death, non-cardiovascular death, acute kidney injury, renal replacement therapy including dialysis, other complications, and adverse events will also be evaluated.
Management information
Registered date
| 2026 | Year | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072300
