UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049148 |
|---|---|
| Receipt number | R000055986 |
| Scientific Title | Effects of Oral Care on Outcomes in Admitted Patients with Heart Failure |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2023/10/08 13:01:34 |
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Basic information
Public title
Effects of Oral Care on Outcomes in Admitted Patients with Heart Failure
Acronym
OCAT-HF
Scientific Title
Effects of Oral Care on Outcomes in Admitted Patients with Heart Failure
Scientific Title:Acronym
OCAT-HF
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Randomized Prospective Interventional Study to Examine the Effect of Oral Care Intervention on the Outcomes of Heart Failure Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to onset of heart failure event or cardiovascular death
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Specialized Oral Care
Interventions/Control_2
Standard Oral Care
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
1. Patients who have given their written consent to participate in this study
2. Patients aged 20 years or older at the time of consent
3. Patients hospitalized for worsening heart failure with symptoms of heart failure
4. NYHA classification 2-4
5. Patients who can be randomized within 7 days after this hospitalization
6. Patients who meet the following criteria for natriuretic peptide from 48 hours prior to this admission to the time of eligibility determination
BNP over 200 pg/mL
Key exclusion criteria
1. Patients with severe renal dysfunction (eGFR under 30 mL/min/1.73 m2), patients on maintenance dialysis, patients with known bilateral renal artery stenosis (known renal artery stenosis in the remaining kidney in patients with one kidney)
2. Patients with severe hepatic dysfunction (Child-Pugh classification C)
3. Patients with cardiogenic shock
4. Patients on cardiopulmonary assist devices, left ventricular assist ventricular assist devices, or ventilators
5. Patients with acute coronary syndrome or stroke within 30 days prior to randomization
6. Patients with a history of surgical or percutaneous treatment for cardiovascular disease within 30 days of randomization.
7. Patients with a preplanned coronary reconstruction or surgical or percutaneous treatment for cardiovascular disease during the individual observation period.
8. Patients with a preplanned treatment such as electrical cardioversion, cardiac resynchronization therapy or pacemaker implantation during the individual observation period.
9. Patients with obstructive hypertrophic cardiomyopathy or a history of or concomitant infiltrative cardiomyopathy such as amyloidosis or sarcoidosis
10. Patients with active pericardial disease
11. Patients with a history of dental visits to other hospitals within 3 months or currently undergoing dental treatment for dental caries, etc.
12. Patients with a history of or on the waiting list for a heart transplant
13. Patients with active infectious diseases or serious chronic respiratory diseases
14. Pregnant, potentially pregnant, or lactating patients
15. Other patients deemed inappropriate for this study by the principal investigator or subinvestigators (e.g., patients with active malignancies)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Shiina |
Organization
Tokyo Medical University
Division name
Department of Cardiology
Zip code
1600023
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
shiina@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Shiina |
Organization
Tokyo Medical University
Division name
Department of Cardiology
Zip code
160-0023
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL
0333426111
Homepage URL
shiina@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
Tokyo Medical University Certified Review Board
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo
Tel
0333426111
IRB@tokyo-med.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
| 2022 | Year | 10 | Month | 17 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055986
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| Registered date | File name |
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