UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058658 |
|---|---|
| Receipt number | R000067076 |
| Scientific Title | The clinical differences based on the subtype of primary aldosteronism: Phase 2 |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/31 16:21:41 |
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Basic information
Public title
The clinical differences based on the subtype of primary aldosteronism: Phase 2
Acronym
The clinical differences based on the subtype of primary aldosteronism: Phase 2
Scientific Title
The clinical differences based on the subtype of primary aldosteronism: Phase 2
Scientific Title:Acronym
The clinical differences based on the subtype of primary aldosteronism: Phase 2
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to elucidate a method for differentiating between various phenotypes of primary aldosteronism without the use of adrenal venous sampling, with a focus on the clinical characteristics of primary aldosteronism. Additionally, while the gold standard for the definitive diagnosis of primary aldosteronism currently involves inpatient load tests, this study aims to identify a more convenient method for distinguishing between essential hypertension and primary aldosteronism by comparing and analyzing their clinical features. Since the reference values for load tests used in the diagnosis of primary aldosteronism differ across countries, the phenotypes diagnosed may also vary slightly. By conducting an international collaborative study, this research will contribute to the identification of more widely applicable diagnostic markers.
Basic objectives2
Others
Basic objectives -Others
The analysis of proteins presumed to be involved in primary aldosteronism using archived samples, comprehensive protein profiling using omics platforms, and the measurement of non-coding RNA.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
age, gender, blood pressure, BMI, blood tests (serum biochemistry test, daily fluctuation of hormones, etc.), urinalysis, confirmatory tests(captopril challenge test, furosemide and upright posture test, saline infusion test), contrast CT examination, adrenal vein sampling, portable polysomnography, ankle brachial pressure index, cardiac ultrasound, abdominal ultrasound, carotid ultrasound
Key secondary outcomes
Proteins presumed to be involved in primary aldosteronism, comprehensive protein profiling using omics platforms, and non-coding RNA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were diagnosed with primary aldosteronism and essential hypertension at Nihon University Itabashi Hospital (January 1, 2006 - January 1, 2030).
2. Patients who were diagnosed with primary aldosteronism and essential hypertension at Institute of Science Tokyo Hospital, Affiliated Hospital of Chongqing Medical University, Monash University, and Hudson Institute of Medical Research (January 1, 2006 - January 1, 2030).
Key exclusion criteria
Patients who refused to participate in this study and the investigator determined to be unsuitable for study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL
+81-3-3972-8111
kobayashi.hiroki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL
+81-3-3972-8111
Homepage URL
kobayashi.hiroki@nihon-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Science Tokyo hospital, Affiliated Hospital of Chongqing Medical University, Monash University, and Hudson Institute of Medical Research
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon university Itabashi hospital clinical reseach center
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
Tel
+81-3-3972-8111
med.itabashi.chiken@nihon-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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
age, gender, blood pressure, BMI, blood tests (serum biochemistry test, daily fluctuation of hormones, etc.), urinalysis, confirmatory tests(captopril challenge test, furosemide and upright posture test, saline infusion test), contrast CT examination, adrenal vein sampling, portable polysomnography, ankle brachial pressure index, cardiac ultrasound, abdominal ultrasound, carotid ultrasound,proteins presumed to be involved in primary aldosteronism, comprehensive protein profiling using omics platforms, and non-coding RNA,etc.
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067076
