UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053521 |
|---|---|
| Receipt number | R000061082 |
| Scientific Title | Hokuriku-plus Heart Failure Registry Study |
| Date of disclosure of the study information | 2024/02/02 |
| Last modified on | 2024/02/08 08:59:59 |
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Basic information
Public title
Hokuriku-plus Heart Failure Registry Study
Acronym
Hokuriku-plus HF Registry
Scientific Title
Hokuriku-plus Heart Failure Registry Study
Scientific Title:Acronym
Hokuriku-plus HF Registry
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish a clinical database as a foundation for the prognosis of patients with heart failure by the prospective registration. Additionally, the use of digital devices is a distinctive feature of this registry study. By integrating various biometric data obtained from digital devices with the foundational database information and analyzing them, we aim to establish new clinical indicators (heart failure index, digital biomarkers) related to the prognosis of heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite cardiac events (Death, heart failure hospitalization, and heart failure exacerbation)
Key secondary outcomes
Vital signs (blood pressure), NYHA classification, blood tests (BNP/NT-proBNP), echocardiography (LVEF, GLS), SPPB score, J-CHS score, PHQ-9 score
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) Age at consent 18 years or older
2) Gender is not specified
3) Whether outpatient or inpatient does not matter
4) At the time of participant registration, has a diagnosis related to heart failure,
or
has a blood NT-proBNP level of 300 pg/mL or higher (or BNP 100 pg/mL or higher)
1. Regardless of acute or chronic
2. Regardless of left, right, or both sides of the heart
3. Regardless of the underlying disease of heart failure
4. Regardless of HFrEF, HFmrEF, HFpEF, or HF-improved
Key exclusion criteria
1) Implanted with a ventricular assist device
2) Have difficulty in regular visits or answering questionnaires due to dementia, mental disorders, etc.
3) Other cases deemed inappropriate by the principal investigator or co-investigators
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
College of Transdisciplinary Sciences for Innovation / Department of Cardiovascular Medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652049
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
College of Transdisciplinary Sciences for Innovation / Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652049
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Akihiro Nomura
Funding Source
Organization
AMI, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
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
金沢大学附属病院(石川県)、国立病院機構金沢医療センター(石川県)、石川県立中央病院(石川県)、心臓血管センター金沢循環器病院(石川県)、松任石川中央病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 02 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among outpatients or inpatients who are eligible for this study, those who received an explanation of the study and gave their consent will have their baseline clinical information (demographics, clinical exam findings, disease characteristics, and various test results) collected from electronic medical records around the time of their outpatient visit or during their hospital stay. Subsequently, clinical information up to 52 weeks post-registration will be prospectively collected according to the observation schedule. All these clinical data will be entered and managed using an Electronic Data Capture system.
Follow-ups will be conducted 4 weeks after case registration, 12 weeks, 26 weeks, and 52 weeks, during which digital phonocardiograms, electrocardiograms, and echocardiographic exams (except at 4 weeks for echocardiography) as well as clinical information will be collected. Information on cardiac events and their dates will also be continuously collected.
In this study, in addition to the usual clinical items for heart failure, biospecimens for analysis will be collected at the time of registration. Additionally, biometric data observation using a smart band will be conducted concurrently for up to one month from registration. Furthermore, questionnaires on the depression scale (PHQ-9) will be added at weeks 0 and 52.
Management information
Registered date
| 2024 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061082
| Research Plan | |
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| 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 |
