UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053285 |
|---|---|
| Receipt number | R000060781 |
| Scientific Title | Investigation on the expectations for surgical treatment in patients with primary aldosteronism |
| Date of disclosure of the study information | 2024/01/06 |
| Last modified on | 2024/07/10 17:14:44 |
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Basic information
Public title
Investigation on the expectations for surgical treatment in patients with primary aldosteronism
Acronym
Investigation on the expectations for surgical treatment in patients with primary aldosteronism
Scientific Title
Investigation on the expectations for surgical treatment in patients with primary aldosteronism
Scientific Title:Acronym
Investigation on the expectations for surgical treatment in patients with primary aldosteronism
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The diagnosis of unilateral or bilateral primary aldosteronism is currently made using the Laterality Ratio (LR) derived from invasive adrenal vein sampling. However, due to the nature of the disease, it is difficult to completely distinguish between the two, and any cutoff value for LR used to determine unilateral aldosteronism will inevitably include a certain proportion of bilateral cases. In other words, the cure rate in surgical treatment greatly depends on where the LR cutoff value is set. Therefore, this study aims to clarify the expectations of patients with primary aldosteronism regarding the effectiveness (cure rate) of surgical treatment through a survey.
Basic objectives2
Others
Basic objectives -Others
"The study aims to clarify, through a survey, the expectations of patients with primary aldosteronism regarding the effectiveness (cure rate) of surgical treatment from their perspective. Based on these survey results, a laterality ratio will be established that is grounded in these findings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the effectiveness (cure rate) of surgical treatment for primary aldosteronism expected by patients.
Key secondary outcomes
factors considered by patients that influence the decision to undergo surgery, 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), CT scans, adrenal vein sampling, portable polysomnography, ankle brachial pressure index, cardiac ultrasound, abdominal ultrasound, carotid ultrasound, data related to treatment (antihypertensive drugs, diabetes treatment drugs, including lipid disorder treatment medications), data on lifestyle habits (smoking status, drinking status), and prognostic data (cardiovascular events, date of last follow-up)
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
Patients who visited the Nihon University Itabashi Hospital between January 2006 and March 2026, and who were diagnosed with primary aldosteronism or suspected of having it, and consented to participate in the study.
Key exclusion criteria
Patients who refused to participate in this study and the investigator determined to be unsuitable for study
Target sample size
200
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
Nihon University
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
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
| 2024 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38747468/
Number of participants that the trial has enrolled
82
Results
For surgical treatment of primary aldosteronism, the median minimum treatment success rate that patients expect when undergoing surgery is 80%.
Results date posted
| 2024 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 15 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 10 | Day |
Other
Other related information
This study is an observational study in which the primary outcome is the effectiveness (cure rate) of surgical treatment for primary aldosteronism expected by patients.
Management information
Registered date
| 2024 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060781
