UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051595 |
|---|---|
| Receipt number | R000058865 |
| Scientific Title | Comparison of treatment status of patients with acute heart failure before and after the spread of COVID19 infection (Cohort observational study using DPC data) |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/07/12 18:02:37 |
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Basic information
Public title
Comparison of treatment status of patients with acute heart failure before and after the spread of COVID19 infection
Acronym
Comparison of treatment status of patients with acute heart failure before and after the spread of COVID19 infection
Scientific Title
Comparison of treatment status of patients with acute heart failure before and after the spread of COVID19 infection (Cohort observational study using DPC data)
Scientific Title:Acronym
Comparison of treatment status of patients with acute heart failure before and after the spread of COVID19 infection
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to compare NPPV usage on admission days before and after the COVID-19 emergency declaration in COVID-19 non-infected acute heart failure inpatients who were urgently transported to a COVID-19 receiving facility. The secondary purpose is to compare the length of hospital stay, in-hospital death, tracheal intubation, high-flow oxygen therapy and cardiac rehabilitation, and the prescription conditions such as frosemid before and after the spread of COVID-19 infection in the target patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
-Implementation of NPPV
Key secondary outcomes
- Hospitalization period
- In-hospital death
- Implementation of tracheal intubation
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
| 19 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COVID-19 during each enrollment period before and after the declaration of an emergency,the name of injury or illness that triggered hospitalization was heart failure(see Table 8-5) and the patient was admitted to the emergency medical care hospital (the same patient was present).If so, give priority to the first hospitalization)
Key exclusion criteria
- Patients under the age of 18 as of Index Date.
- Patients undergoing dialysis within 2 days after admission.
- Patients with COVID-19 diagnosis (ICD-10: U07.1 COVID19 virus, identified) from 1 year before admission to the date of discharge.
- Patients with a diagnosis of respiratory infection (tonsillitis, upper respiratory tract inflammation, influenza, viral pneumonia, pneumonia, aspiration pneumonia, etc.) at the time of admission.
- Patients with "acute respiratory distress syndrome (J80)", "end-stage renal failure (N185)", "cardiopulmonary arrest at admission (I469)" at admission.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Mastukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
5400021
Address
3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan
TEL
06-6943-7722
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
5400021
Address
3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan
TEL
08067917646
Homepage URL
matsukawa.miyuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd. Research Division Research Ethics Committee
Address
463-10 Kagasuno, Kawauchi Town, Tokushima City, Tokushima Prefecture
Tel
088-665-2126
Imaizumi.Takashi@otsuka.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
| 2023 | Year | 08 | Month | 10 | 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
11909
Results
We found a significant decrease in NPPV implementation rate in the eligible patient population, and a decreasing trend in COVID-19 receiving facilities and emergency declaration response areas. Tracheal intubation was increased in all populations. In addition, the financial burden associated with the treatment for acute HF notably increased following the pandemic. The COVID-19 pandemic substantially affected our clinical practices in patients with acute HF.
Results date posted
| 2023 | Year | 07 | Month | 12 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058865
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| Registered date | File name |
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