UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058522 |
|---|---|
| Receipt number | R000066922 |
| Scientific Title | Clinical utility of symptom management with pocket echocardiography for elderly patients with chronic heart failure |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/19 14:17:49 |
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Basic information
Public title
Clinical utility of symptom management with pocket echocardiography for elderly patients with chronic heart failure
Acronym
Effectiveness of symptom management approach with pocket echocardiography for elderly patients with chronic heart failure
Scientific Title
Clinical utility of symptom management with pocket echocardiography for elderly patients with chronic heart failure
Scientific Title:Acronym
Effectiveness of symptom management approach with pocket echocardiography for elderly patients with chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Medicine in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to the assessment of the inferior vena cava using pocket echocardiography is associated with clinical evaluations in elderly patients with chronic heart failure who are receiving outpatient care or home visits.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inferior vena cava, Brain Natriuretic Peptide
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
heart failure by Framingham Study 1) more than 20 years old 2) home or nursing home
Key exclusion criteria
less than 20 years old
Acute coronary syndrome
End-stage renal failure
serious co-morbidities that may affect endpoints
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kimori |
Organization
Komatsu university
Division name
Faculty of health science, Department of Nursing
Zip code
9230961
Address
He 14-1 Mukaimotoorimachi, Komatsu, Ishikawa, Japan
TEL
0761483175
keiko.kimori@komatsu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kimori |
Organization
Komatsu University
Division name
Faculty of health science, Department of Nursing
Zip code
9230961
Address
He 14-1 Mukaimotoorimachi, Komatsu, Ishikawa, Japan
TEL
0761483175
Homepage URL
keiko.kimori@komatsu-u.ac.jp
Sponsor or person
Institute
Komatsu University
Institute
Department
Personal name
Funding Source
Organization
Komatsu University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komatsu University
Address
He 14-1 Mukaimotoorimachi, Komatsu, Ishikawa
Tel
0761483175
keiko.kimori@komatsu-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
石川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 25 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | 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
Symptoms, clinical examinations, environment, and self-care behaviors and body position of outpatients with chronic heart failure
Management information
Registered date
| 2025 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066922
