UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049086 |
|---|---|
| Receipt number | R000055894 |
| Scientific Title | Renal safety of analgesics in patients with Cardiovascular disease ; A descriptive study using a real world database |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2023/10/03 07:02:41 |
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Basic information
Public title
Renal safety of analgesics in patients with Cardiovascular disease ; A descriptive study using a real world database
Acronym
Renal safety of analgesics in patients with Cardiovascular disease ; A descriptive study using a real world database
Scientific Title
Renal safety of analgesics in patients with Cardiovascular disease ; A descriptive study using a real world database
Scientific Title:Acronym
Renal safety of analgesics in patients with Cardiovascular disease ; A descriptive study using a real world database
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate renal safety of analgesics in patients with heart failure
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Proportion of analgesics use in heart failure patients
- Categories at baseline and sequential changes of renal function after administration of analgesics in patients with heart failure (eGFR or serum creatinine level)
Key secondary outcomes
- Proportion and frequency of combination therapy other than analgesics (especially focusing on Triple Warmy Drugs) by category
- For analgesics, proportion of concomitant use, daily and cumulative dose distribution, and proportion of single use
- Distribution of registered comorbidities
- Sequential changes of biomarker [index] in patients with heart failure from baseline (BNP or NT-proBNP) (BNP or NT-proBNP)
- Incidence proportion of heart failure exacerbation events (hospitalization due to heart failure, administration of intravenous diuretics, and increased dose of oral diuretic)
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
Patients with heart failure (ICD-10 code: I50x) and BNP or NT-proBNP measurements
Key exclusion criteria
cancer, surgery, pregnancy
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sato |
Organization
Kawaguchi Cardiovascular and Respiratory Hospital
Division name
cardiology
Zip code
333-0842
Address
1-51 Maekawa 1-Chome, Kawaguchi-city, Saitama, Japan
TEL
048-264-5533
nms-ns@nms.ac.jp
Public contact
Name of contact person
| 1st name | Toshi |
| Middle name | |
| Last name | Takano |
Organization
AYUMI PHARMACEUTICAL CO., LTD
Division name
Medical Affairs Div.
Zip code
104-0061
Address
12-15 Ginza 4-Chome, Chuo-ku, Tokyo, Japan
TEL
0362643530
Homepage URL
toshio.takano@ayumi-pharma.com
Sponsor or person
Institute
Kawaguchi Cardiovascular and Respiratory Hospita
Institute
Department
Personal name
Funding Source
Organization
AYUMI PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kurashiki Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Central Hospital Ethics Committee
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
kenkyu@kchnet.or.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 | 03 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A descriptive study using anonymously processed information in a Japanese healthcare database.
No formal sample size calculation was conducted for the present study due to the nature of database study.
Management information
Registered date
| 2022 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
