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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039787
Receipt No. 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 2021/07/08

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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
Email 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
Email cardiostudy@ml.cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
Email 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 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 No longer recruiting
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
2021 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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