UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037446 |
|---|---|
| Receipt number | R000042671 |
| Scientific Title | Investigation of relationship between sleep disordered breathing and pulmonary hemodynamics in pulmonary hypertension |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2020/05/19 15:00:24 |
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Basic information
Public title
Investigation of relationship between sleep disordered breathing and pulmonary hemodynamics in pulmonary hypertension
Acronym
Pulmonary hypertension and sleep disordered breathing
Scientific Title
Investigation of relationship between sleep disordered breathing and pulmonary hemodynamics in pulmonary hypertension
Scientific Title:Acronym
Pulmonary hypertension and sleep disordered breathing
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of sleep disordered breathing (SDB) and the association between the severity of SDB and pulmonary hemodynamics
Basic objectives2
Others
Basic objectives -Others
To investigate the result of Watch-PAT and pulmonary hemodynamics measured by right heart catheter (RHC)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between PAT-AHI by Watch-PAT and the pulmonary hemodynamics measured by RHC
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
Inclusion criteria of patients are as follows;
1)Patients who were suspected of having PAH or CTEPH and hospitalized for RHC
2) Patients who had SDB examination by Watch-PAT
3)Patients give written informed consent
Key exclusion criteria
Patients with any condition, in the opinion of the investigator, have the limitation of ability to comply with the study requirements or impact the interpretability of study results
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Naito |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, 260-8670, Japan
TEL
043-222-7171
akira_n_med-respi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Naito |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, 260-8670, Japan
TEL
043-222-7171
Homepage URL
akira_n_med-respi@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of the Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba City, 260-8670, Japan
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is an observational study to analyze the association between PAT-AHI by Watch-PAT and the pulmonary hemodynamics measured by right heart catheter
Management information
Registered date
| 2019 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042671
