UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060681 |
|---|---|
| Receipt number | R000069411 |
| Scientific Title | Efficacy of swallowing function assessment and intervention in patients with heart failure |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/16 12:01:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of swallowing function assessment and intervention in patients with heart failure
Acronym
Assessment of swallowing function and intervention in heart failure
Scientific Title
Efficacy of swallowing function assessment and intervention in patients with heart failure
Scientific Title:Acronym
Assessment of swallowing function and intervention in heart failure
Region
| Japan |
Condition
Condition
Acute or acutely decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether an early in-hospital assessment of swallowing function, followed by dental interventions when indicated, reduces future aspiration pneumonia and subsequent rehospitalizations for heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospitalization due to aspiration pneumonia
Key secondary outcomes
Heart failure rehospitalization, hospital period
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Assessment of swallowing function using EAT-10
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
| 75 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions:
Patients aged 75 to 85 years who require hospitalization in the Department of Cardiology at Kasugai Municipal Hospital for acute heart failure or acute exacerbation of chronic heart failure.
Patients for whom a heart failure notebook can be used (those without severe dementia and with preserved self-care ability).
Key exclusion criteria
Patients who meet any of the following conditions:
Patients who refuse swallowing assessment or interventions.
Patients with a history of aspiration pneumonia.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Oguri |
Organization
Kasugai Municipal Hospital
Division name
Department of Cardiology
Zip code
4868510
Address
1-1-1 Takaki-cho, Kasugai, Japan
TEL
0568570057
oguricap0909@gmail.com
Public contact
Name of contact person
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Oguri |
Organization
Kasugai Municipal Hospital
Division name
Department of Cardiology
Zip code
4868510
Address
1-1-1 Takaki-cho, Kasugai, Japan
TEL
0568570057
Homepage URL
oguricap0909@gmail.com
Sponsor or person
Institute
Kasugai Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Kasugai Municipal Hospital
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
Kasugai Municipal Hospital
Address
1-1-1 Takaki-cho, Kasugai, Japan
Tel
0568570057
chikenjimukyoku@hospital.kasugai.aichi.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 | 16 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069411
