UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051428 |
|---|---|
| Receipt number | R000058656 |
| Scientific Title | Hokuriku-Plus Acute Decompensation Heart Failure Registry |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/23 08:32:26 |
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Basic information
Public title
Hokuriku-Plus Acute Decompensation Heart Failure Registry
Acronym
Hokuriku-Plus Acute Decompensation Heart Failure Registry
Scientific Title
Hokuriku-Plus Acute Decompensation Heart Failure Registry
Scientific Title:Acronym
Hokuriku-Plus Acute Decompensation Heart Failure Registry
Region
| Japan |
Condition
Condition
Acute Decompensation Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual situation of acute noncompensated heart failure in actual clinical practice in the Hokuriku region.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Death (cardiovascular and non-cardiovascular)
Key secondary outcomes
Hospitalization for cardiovascular causes (heart failure, acute myocardial infarction, stroke, other), hospitalization for heart failure
Hospitalization for any cause, changes in blood BNP levels, changes in echocardiographic findings,
mRNA expression analysis of blood cells
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with acute decompensated heart failure
Key exclusion criteria
(1) Patients after heart transplantation
(2) Patients with acute coronary syndrome requiring urgent revascularization
(3) Other patients who are judged by the physician in charge to be inappropriate as research subjects.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Usui |
Organization
Kanazawa University
Division name
Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
0762652259
usuiso@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Usui |
Organization
Kanazawa University
Division name
Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
0762652259
Homepage URL
usuiso@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Soichiro Usui
Funding Source
Organization
None
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
Medical Ethics Committee of Kanazawa University
Address
13-1 Takaramachi Kanazawa, Ishikawa, Japan
Tel
0762652110
rinri@adm.kanazawa-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
| 2023 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 18 | 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
Observations, tests, and reportable items
Basic items: date of birth (A.D.), sex, height, weight, social factors (living alone, living with others, welfare status), heart failure stage classification (C or D)
Physical examination (on admission): severity (NYHA cardiac function classification), type of clinical scenario (CS; 1,2,3,4,5), blood pressure, pulse rate, respiratory rate, presence of leg edema.
Family history: presence or absence of family history.
Preference history: presence or absence of smoking.
Comorbidities:
Severity of illness (at discharge): NYHA classification, clinical frailty scale, grip strength, AT level, 6-minute walk distance
Laboratory findings: general blood tests, ECG, echocardiography
PAXgene Blood RNA
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058656
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
