UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044603 |
|---|---|
| Receipt number | R000050947 |
| Scientific Title | Prospective Area Registry of ARNI for Congestive heart failUre in Tokyo East |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/06/20 22:32:49 |
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Basic information
Public title
Prospective Area Registry of ARNI for Congestive heart failUre in Tokyo East
Acronym
Prospective Area Registry of ARNI for Congestive heart failUre in Tokyo East
Scientific Title
Prospective Area Registry of ARNI for Congestive heart failUre in Tokyo East
Scientific Title:Acronym
Prospective Area Registry of ARNI for Congestive heart failUre in Tokyo East
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify predictors of sacubitril/valsartan responder in Japanese
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular ejection fraction
Key secondary outcomes
1) NT-pro BNP
2) ANP
3) BUN/Cr/eGFR
4) Vital signs
5) NYHA classification
6) Cardio Thoracic Ratio
7) Transthoracic echocardiography data
8) All cause death, cardiovascular death, all cause hospitalization, hospitalization for heart failure
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
Congestive heart failure patients who start taking sacubitril/valsartan
Key exclusion criteria
1) Contraindication for sacubitril/valsartan
2) systolic blood pressure <95 mmHg
3) eGFR<30 mL/min/1.73m2
4) serum K>5.5 mEq/L
5) BNP<100 pg/mL or NT-pro BNP<300 pg/mL
6) Patients with expected survival of 12 months or less
7) Patients that the doctor deems inappropriate for participation in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKURO |
| Middle name | |
| Last name | ABE |
Organization
Nishiarai heart center hospital
Division name
Cardiology
Zip code
123-0845
Address
1-12-8, Nishiarai honcho, Adachi-ku, Tokyo
TEL
03-5838-0730
abetakuro1009@gmail.com
Public contact
Name of contact person
| 1st name | TAKURO |
| Middle name | |
| Last name | ABE |
Organization
Nishiarai heart center hospital
Division name
Cardiology
Zip code
123-0845
Address
1-12-8, Nishiarai honcho, Adachi-ku, Tokyo
TEL
03-5838-0730
Homepage URL
abetakuro1009@gmail.com
Sponsor or person
Institute
Nishiarai heart center hospital
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
Nishiarai heart center hospital
Address
1-12-8, Nishiarai honcho, Adachi-ku, Tokyo
Tel
03-5838-0730
abetakuro1009@gmail.com
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
| 2021 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2021 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050947
| 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 |
