UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026433 |
|---|---|
| Receipt number | R000030355 |
| Scientific Title | Prospective surveillance study of pulmonary hypertensionfor Japanese patients in Tokai region |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2025/03/19 08:51:48 |
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Basic information
Public title
Prospective surveillance study of pulmonary hypertensionfor Japanese patients in Tokai region
Acronym
NAGOYA PH Registry
Scientific Title
Prospective surveillance study of pulmonary hypertensionfor Japanese patients in Tokai region
Scientific Title:Acronym
NAGOYA PH Registry
Region
| Japan |
Condition
Condition
Pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze outcomes in Japanese patients with pulmonary hypertension
Basic objectives2
Others
Basic objectives -Others
To analyze baseline characteristics in Japanese patients with pulmonary hypertension
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause death.
worsening of pulmonary arterial hypertension.
Key secondary outcomes
Death due to pulmonary hypertension or hospitalization for worsening of pulmonary arterial hypertension.
Change in the hemodynamics.
Change in the subjective symptoms.
Change in the laboratory data.
Change in the echocardiographic parameters.
Change in the home oxygen therapy.
Hospitalization except for the cause of worsening pulmonary hypertesion.
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pulmonary hypertension which defined by a mean pulmonary artery pressure more than 25 mmHg at rest
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University
Division name
Nagoya University Graduate School of Medicine Department of Carediology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-0388
adachi.shiro.b6@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University
Division name
Nagoya University Graduate School of Medicine Department of Carediology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-0388
Homepage URL
adachi.shiro.b6@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Operating expenses of donated course
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
Nagoya University
Address
Nagoya-city Showa-ku Tsurumai65
Tel
052-744-0388
adachi.shiro.b6@f.mail.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 07 | 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
Date of protocol fixation
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study aiming for clinical outcomes in patients with pulmonary hypertension
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030355
