UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038078 |
|---|---|
| Receipt number | R000043398 |
| Scientific Title | A Clinical Study of CABs during CPX test in Patients with Heart Failure |
| Date of disclosure of the study information | 2019/09/23 |
| Last modified on | 2023/03/25 17:13:17 |
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Basic information
Public title
A Clinical Study of CABs during CPX test in Patients with Heart Failure
Acronym
ACARE2-HF
Scientific Title
A Clinical Study of CABs during CPX test in Patients with Heart Failure
Scientific Title:Acronym
ACARE2-HF
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the previous study (UMIN 000028335), we have reported the correlation between changes in CABs (Cardiac Acoustic Biomarkers) calculated from Electrocardiogram and Heart Sounds, and AT points confirmed by conventional CPX inspection in patients with chronic heart failure. In this study, we verify the algorithm to calculate AT point obtained in the previous study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When CABs are analyzed with the algorithm obtained in the previous study, the correlation coefficient with the AT point determined from the conventional CPX inspection conducted in this study should be 0.7 or more.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with Heart Failure
2)Who are selected for cardiac rehabilitation and are able to perform CPX
3)Who gave written informed consent
Key exclusion criteria
1)Patients with unstable condition after Acute Heart Failure
2)Patients who have atrial fibrillation or combined valvular disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Iida |
Organization
Nihon University Hospital
Division name
Cardiology
Zip code
101-8309
Address
1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan
TEL
03-3293-1711
kiida2830@gmail.com
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Fujimoto |
Organization
Nihon University Hospital
Division name
Cardiology
Zip code
101-8309
Address
1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
fujimoto.nobuko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6 Kanda Surugadai, Chiyoda, Tokyo, Japan
Tel
03-3293-1711
kiida2830@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
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 23 | 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
40
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
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the previous study (UMIN 000028335), we have reported the correlation between changes in CABs (Cardiac Acoustic Biomarkers) calculated from Electrocardiogram and Heart Sounds, and AT points confirmed by conventional CPX inspection in patients with chronic heart failure. In this study, we verify the algorithm to calculate AT point obtained in the previous study.
Management information
Registered date
| 2019 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043398
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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