UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044351 |
|---|---|
| Receipt number | R000050652 |
| Scientific Title | Underlying factors related to up-titration of sacubitril/valsartan in patients with heart failure |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/01/22 15:45:25 |
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Basic information
Public title
Underlying factors related to up-titration of sacubitril/valsartan in patients with heart failure
Acronym
Underlying factors related to up-titration of sacubitril/valsartan
Scientific Title
Underlying factors related to up-titration of sacubitril/valsartan in patients with heart failure
Scientific Title:Acronym
Underlying factors related to up-titration of sacubitril/valsartan
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors linked to up-titration of sacubitril/valsartan in patients with heart failure
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of clinical factors between patients with and without up-titration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with sacubitril/valsartan initiation in our hospital
Key exclusion criteria
Patients have already received sacubitril/valsartan in other hospital
Lacking of follow-up information
Target sample size
175
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kindai University
Address
377-2, Ohnohigashi, Osakasayama
Tel
+81723660221
kmatsumura1980@yahoo.co.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
東海大学医学部付属病院（神奈川県）、枚方公済病院（大阪府）、八尾市立病院（大阪府）、有田市立病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/10742484221146375
Number of participants that the trial has enrolled
320
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
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2021 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
