UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042693 |
|---|---|
| Receipt number | R000048723 |
| Scientific Title | The retrospective exploration for the new type of medicines for congestive heart failure |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/12/08 23:17:04 |
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Basic information
Public title
The retrospective exploration for the new type of medicines for congestive heart failure
Acronym
The retrospective exploration for the new type of medicines for congestive heart failure
Scientific Title
The retrospective exploration for the new type of medicines for congestive heart failure
Scientific Title:Acronym
The retrospective exploration for the new type of medicines for congestive heart failure
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the patients who are treated by the new medicines for congestive heart failure examined by echocardiography and many other modalities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The echocardiographic indices
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The patients who are treated with Ivabrazin, Dapagliflozin, Sacubitril valsartan sodium hydrate
2. The patients with examination with blood test and echocardiography
Key exclusion criteria
Discontinuation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Iwahashi |
Organization
Yokohama City University Medical center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Yokohama
TEL
045-261-5656
niwahash@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Iwahashi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Minami-ku Yokohama
TEL
045-261-5656
Homepage URL
niwahash@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YCU novel and clinical trail center
Address
3-9 Fukura Kanazawa-ku Yokohama
Tel
0457872800
nextjim1@yokohama-cu.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
| 2020 | Year | 12 | Month | 31 | 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
| 2020 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective
Management information
Registered date
| 2020 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048723
