UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046631 |
|---|---|
| Receipt number | R000053196 |
| Scientific Title | Advancing Care of Primary Aldosteronism in Japan Study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/07/17 09:13:14 |
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Basic information
Public title
Advancing Care of Primary Aldosteronism in Japan Study
Acronym
Japan Primary Aldosteronism Study 2
Scientific Title
Advancing Care of Primary Aldosteronism in Japan Study
Scientific Title:Acronym
Japan Primary Aldosteronism Study 2
Region
| Japan |
Condition
Condition
primary aldosteronsim:PA
essential hypertension:EHT
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Endocrine surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve quality of clinical practice of PA and to establish evidence for the clinical guideline of severe form of PA based on 3 clinical questions as followed;
1) prediction score for subtype diagnosis of PA by non-invasive methods,2) standard protocol and decision criteria of adrenal venous sampling(AVS), 3) difference of the effects between surgical and medical treatments of PA, 4)development of highological biomarkers for diagnosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
1) baseline information,biochemical data, results of confirmatory tests, imaging findings and post-treatment outcomes
2) protocol,decision criteria of AVS
3) treatments and outcomes
4) cost effectiveness
Key secondary outcomes
1)Pathological findings
2)Markers of target organ damage:Kidney(eGFR,BUN,Cr),Heart(ECG,CTR)
3)Clinical course(6M,1Y,3Y,5Y):base line informations, Laboratory data
4)Immunohistochemical staining
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as PA or EHT between January 2006 and Mar 2026 in JPAS 2 participating centers
Key exclusion criteria
Patients who were judged not eligible for the study by respective attending physician
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Sone |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
jpas2@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Yokota |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
jpas2@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
jpas2@marianna-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
| 2022 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, observation study.
Management information
Registered date
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053196
