UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060712 |
|---|---|
| Receipt number | R000069459 |
| Scientific Title | Comprehensive Survey for Optimizing Cardiovascular Disease Management in Chronic Care Settings: Identification of Undiagnosed Heart Failure and Clinical Practice of the 2025 Hypertension Guidelines |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2026/02/20 13:57:11 |
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Basic information
Public title
Comprehensive Survey for Optimizing Cardiovascular Disease Management in Chronic Care Settings: Identification of Undiagnosed Heart Failure and Clinical Practice of the 2025 Hypertension Guidelines
Acronym
Comprehensive Survey for Optimizing Cardiovascular Disease Management in Chronic Care Settings
Scientific Title
Comprehensive Survey for Optimizing Cardiovascular Disease Management in Chronic Care Settings: Identification of Undiagnosed Heart Failure and Clinical Practice of the 2025 Hypertension Guidelines
Scientific Title:Acronym
Comprehensive Survey for Optimizing Cardiovascular Disease Management in Chronic Care Settings
Region
| Japan |
Condition
Condition
Heart Failure and Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to comprehensively clarify the current state of cardiovascular practice within a chronic care setting. The specific aims are as follows:
1) To determine the precise prevalence of latent heart failure comorbid with other conditions among inpatients through comprehensive screening (ECG, echocardiography, and NT-proBNP), and to evaluate the impact of heart failure on clinical outcomes during hospitalization.
2) To assess the achievement rates of blood pressure targets based on the 2025 Japanese Society of Hypertension (JSH 2025) guidelines through a cross-sectional study of hypertensive outpatients, while identifying specific barriers to goal attainment, including clinical inertia and discrepancies in clinical judgment across medical departments.
3) To optimize institutional clinical protocols by establishing "Standard Cardiovascular Care Protocols" based on the obtained evidence, thereby contributing to the overall improvement of the quality of care within the facility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of latent (Stage B) heart failure in hospitalized patients, and Hypertension control rate based on the JSH 2025 guidelines
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) Screening and Identification of Latent Heart Failure among Inpatients
All inpatients aged 18 years and older at our hospital
2) Investigation of the Clinical Implementation and Adherence to the JSH 2025 (Japanese Society of Hypertension) Guidelines for Hypertension Management
All outpatients aged 18 years and older diagnosed with hypertension at our hospital
Key exclusion criteria
1) Screening and Identification of Latent Heart Failure among Inpatients
Patients who did not undergo heart failure screening (ECG, echocardiography, and NT-proBNP measurement) at the time of admission.
2) Investigation of the Clinical Implementation and Adherence to the JSH 2025 (Japanese Society of Hypertension) Guidelines for Hypertension Management
Patients diagnosed with secondary hypertension.
Patients for whom blood pressure measurement is difficult due to mental or physical reasons.
Duplicate entries for the same patient.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kimura |
Organization
Tomei Hospital, Tachibanakai Medical Corporation
Division name
Department of Cardiology
Zip code
480-1153
Address
1-1110 Sakuda, Nagakute, Aichi 480-1153, Japan
TEL
0561-62-7511
zephyr2sr17circ@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kimura |
Organization
Tomei Hospital, Tachibanakai Medical Corporation
Division name
Department of Cardiology
Zip code
480-1153
Address
1-1110 Sakuda, Nagakute, Aichi 480-1153, Japan
TEL
0561-62-7511
Homepage URL
zephyr2sr17circ@gmail.com
Sponsor or person
Institute
Tomei Hospital, Tachibanakai Medical Corporation
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
Nagoya University Certified Clinical Research Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
iga-shinsa@t.mail.nagoya-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
| 2026 | Year | 02 | Month | 20 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center observational study comprises two clinical investigations: (1) screening and identification of latent heart failure among inpatients, and (2) assessment of the clinical implementation and adherence to the JSH 2025 (Japanese Society of Hypertension) guidelines among outpatients.
In the first investigation, clinical data obtained through routine diagnostic procedures at the time of admission (ECG, echocardiography, and NT-proBNP measurement) will be collected and analyzed to investigate the prevalence and clinical characteristics of latent heart failure among inpatients aged 18 and older.
In the second investigation, clinical data obtained through routine care for outpatients aged 18 and older diagnosed with hypertension will be reviewed to evaluate the adherence rate to the JSH 2025 guidelines and the status of blood pressure management.
Both investigations involve only the extraction and analysis of existing medical records (clinical data, test results, etc.). No experimental interventions, such as the assignment of specific medications or additional invasive procedures, will be performed for the purpose of this research.
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069459
