UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056065 |
|---|---|
| Receipt number | R000064066 |
| Scientific Title | The study on phenotyping and predicting prognosis of patients with pulmonary arterial hypertension with cardiopulmonary comorbidities |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/03/28 17:02:54 |
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Basic information
Public title
The study on phenotyping and predicting prognosis of patients with pulmonary arterial hypertension with cardiopulmonary comorbidities
Acronym
CAPLAM study
Scientific Title
The study on phenotyping and predicting prognosis of patients with pulmonary arterial hypertension with cardiopulmonary comorbidities
Scientific Title:Acronym
CAPLAM study
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We define patient characteristics of PAH in Japan. From this, multiple phenotypes will be identified.
Basic objectives2
Others
Basic objectives -Others
We will define the definition and risk factors of PAH with cardiopulmonary comorbidities. In addition, differences in prognosis will be examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality in registered patients
Key secondary outcomes
Lung transplantation, atrial septal perforation, worsening NYHA functional class, conditions requiring clinical intensification with poor reduction in mean PA and PVR with therapeutic intervention, hospitalization for pulmonary hypertension, elevated liver enzymes, edema, other serious drug side effects, pregnancy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Idiopathic and hereditary PAH at age 16 years or older from the date of approval for implementation through December 31, 2028
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University Hospital
Division name
Cardiology
Zip code
4668560
Address
65, Tsurumai-chou, showa-ku, Nagoya-shi, Aichi
TEL
0527412111
sadachi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University Hospital
Division name
Cardiology
Zip code
4668560
Address
65, Tsurumai-chou, showa-ku, Nagoya-shi, Aichi
TEL
0527412111
Homepage URL
sadachi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Japan PH Registry
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 Graduate School of Medicine
Address
65, Tsurumai-chou, showa-ku, Nagoya-shi, Aichi
Tel
0527412111
ethics@med.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
| 2025 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Of the patients enrolled in the JAPHR, those who are 16 years of age or older and have a diagnosis of idiopathic or hereditary pulmonary arterial hypertension during the period from the date of approval for implementation to December 31, 2028 will be analyzed.
Information obtained for medical purposes will be anonymized and data will be analyzed to confirm the course of treatment and drug effects.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064066
