UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045569 |
|---|---|
| Receipt number | R000052019 |
| Scientific Title | A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure |
| Date of disclosure of the study information | 2021/09/25 |
| Last modified on | 2021/09/25 16:25:22 |
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Basic information
Public title
A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Acronym
A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Scientific Title
A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Scientific Title:Acronym
A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify 1) changes in various biomarkers before and after switching from ACE inhibitors or ARBs to ARNI, and 2) the relationship between changes in biomarkers and prognosis, using laboratory data (clinical data, imaging data, blood test results, etc.) from patients with heart failure who had clinical symptoms despite standard treatment according to guidelines and who switched from ACE inhibitors or ARBs to ARNI.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in biomarkers before and after the introduction of ARNI
Key secondary outcomes
(1) Relationship between changes in biomarkers and prognosis
(2) Comparison of the clinical course of information obtained from medical record data.
(3) Correlation with various examinations, symptoms, etc. obtained from the medical record base
(4) Examination of factors involved in the effect of treatment obtained from the medical record base
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
(1) Patients who are 18 years of age or older at the time of obtaining consent.
(2) Patients who have had inadequate response to standard treatment with ACE inhibitor or ARB according to the guidelines.
(3) Patients who have received sufficient explanations and understanding before participating in this study, and who have obtained the free consent of the research subject or his/her guardian.
Key exclusion criteria
(1) Those who are not tolerant of ARNI
(2) Those who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
tnagai@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
tnagai@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2040 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052019
