UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039787 |
|---|---|
| Receipt number | R000045359 |
| Scientific Title | Study of Association between Pulmonary artery pressure and Cardiac acoustic biomarker |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2022/12/26 16:04:44 |
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Basic information
Public title
Study of Association between Pulmonary artery pressure and Cardiac acoustic biomarker
Acronym
Study of Association between Pulmonary artery pressure and Cardiac acoustic biomarker
- SAP-C -
Scientific Title
Study of Association between Pulmonary artery pressure and Cardiac acoustic biomarker
Scientific Title:Acronym
Study of Association between Pulmonary artery pressure and Cardiac acoustic biomarker
- SAP-C -
Region
| Japan |
Condition
Condition
Heart failure patients who are due to undergo right heart catheterization
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the relationship between CAB which captures S2 characteristics, and PAP changes, explores new possibilities of PAP monitoring using CAB, and investigates the relationship with the heart failure state by concurrently analyzing the conventional EMAT and S3 characteristics. Heart sounds and ECG are measured concurrently during right heart catheterization to accurately measure CAB responsiveness to changes in PAP and other hemodynamic indicators related to heart failure.
Basic objectives2
Others
Basic objectives -Others
1. CAB values relating to S2 characteristics measured at the 3L position, and PAP values (peak value during exercise) measured at each of the following points in provocative testing during right heart catheterization: baseline (at rest), exercise (provocation), and cool-down (at rest).
2. CAB values measured at the Apex and 3L positions, and PAP values and hemodynamic indicators other than PAP (PCWP, CO, etc.) measured at each of the following points in provocative testing during right heart catheterization: baseline (at rest), exercise (provocation), cool-down (at rest).
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. CAB values relating to S2 characteristics measured at the 3L position, and PAP values (peak value during exercise) measured at each of the following points in provocative testing during right heart catheterization: baseline (at rest), exercise (provocation), cool-down (at rest).
2. CAB values measured at the Apex and 3L positions, and PAP values and hemodynamic indicators other than PAP (PCWP, CO, etc.) measured at each of the following points in provocative testing during right heart catheterization: baseline (at rest), exercise (provocation), cool-down (at rest).
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
1) Patients who are aged 20 years or older at the time of acquisition of informed consent
2) Heart failure patients who are due to undergo right heart catheterization
3) Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients with severe aortic stenosis or degenerative mitral insufficiency
2) Patients after mechanical valve replacement
3) Patients using assisted circulation apparatus such as LVAD or IABP
4) Patients with complications of malignant tumors
5) Patients who are pregnant, may be pregnant, or are nursing
6) Other patients deemed ineligible at the discretion of the principal investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Node |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2364
cardiostudy@ml.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Kotooka |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2364
Homepage URL
cardiostudy@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
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
Asahi Kasei Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center,Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 26 | 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
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045359
