UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037304 |
|---|---|
| Receipt number | R000042530 |
| Scientific Title | A Comparison between Confirmatory Tests for the Diagnosis of Primary Aldosteronism |
| Date of disclosure of the study information | 2019/07/29 |
| Last modified on | 2020/07/08 12:13:22 |
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Basic information
Public title
A Comparison between Diagnostic Tests for Primary Aldosteronism
Acronym
PA Diagnostic Tests Comparison
Scientific Title
A Comparison between Confirmatory Tests for the Diagnosis of Primary Aldosteronism
Scientific Title:Acronym
PA Confirmatory Tests Comparison
Region
| Japan |
Condition
Condition
Primary Aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary aldosteronism (PA) represents 3-10% of all hypertensive patients. The diagnosis of PA is important, because patients with PA have higher cardiovascular morbidity than patients with essential hypertension. Based on the Consensus Statement on the Clinical Practice of Primary Aldosteronism in Japan published by the Japan Endocrine Society in 2016, PA is diagnosed if one of following four confirmatory tests is positive; the captopril challenge test (CCT), furosemide-upright test (FUP), saline infusion test (SIT), or oral salt-loading test (OST). Because there are no evidences on which confirmatory test is superior than others in terms of sensitivity and specificity, we cannot completely deny PA until all the four tests have been confirmed to be negative. This might be problematic for physicians to diagnose PA for patients referred from general practitioners. In the present study, we analyze correlations among parameters of the four confirmatory tests and compare clinical characteristics between test-positive and test-negative patients for each confirmatory test. This would lead to the simplification of PA diagnosis and the proposal of diagnostic procedure that is appropriate for the clinical condition of each patient.
Basic objectives2
Others
Basic objectives -Others
Comparisons among parameters of different diagnostic tests
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparisons among post-CCT aldosoterone/renin ratio (ARR), plasma aldosterone concentration (PAC), post/pre-CCT PAC ratio, post-FUP plasma renin activitiy (PRA), post-SIT PAC, and post-OST urinary aldosterone excretion.
Key secondary outcomes
Concordance among confirmatory test results. Adverse events in each confirmatory test. Clinical characteristics of test-positive patients among confirmatory tests.
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 for whom at least two of the CCT, SIT, FUP, and oral salt-loading test were performed, (2) patients who did not refuse to be included in the study upon information disclosure of the study on the Web site of Shizuoka General Hospital.
Key exclusion criteria
(1) patients for whom less than two of the confirmatory tests were performed, (2) patients who refused to be included in the study upon information disclosure of the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Tamura |
Organization
Shizuoka General Hospital
Division name
Research Support Center
Zip code
420-8527
Address
4-27-1 Kita Ando, Aoi-ku, Shizuoka City, Japan 420-8527
TEL
054-247-6111
naohisa-tamura@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Tamura |
Organization
Shizuoka General Hospital
Division name
Research Support Center
Zip code
420-8527
Address
4-27-1 Kita Ando, Aoi-ku, Shizuoka City, Japan 420-8527
TEL
054-247-6111
Homepage URL
naohisa-tamura@i.shizuoka-pho.jp
Sponsor or person
Institute
Department of Hypertension Research
Research Support Center
Shizuoka General Hospital
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
Clinical Research Ethics Committee, Shizuoka General Hospital
Address
4-27-1 Kita Ando, Aoi-ku, Shizuoka City
Tel
054-247-6111
chiken-sougou@shizuoka-pho.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
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
142
Results
The plasma aldosterone concentration 60 min after the load of CCT (CCT60-PAC) <=59.0 pg/mL and CCT60-plasma renin activity (PRA) >=1.05 ng/mL/h could predict negativities of SIT and FUP, respectively, with >95% specificities. The present study suggested the SIT as the next test to be done if the CCT-negative patient belonged to the subset with CCT60-PAC >59.0 pg/mL and CCT60-PRA >=1.05 ng/mL/h, otherwise the FUP should be selected.
Results date posted
| 2020 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 03 | 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
| 2017 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparisons among post-CCT aldosoterone/renin ratio (ARR), plasma aldosterone concentration (PAC), post/pre-CCT PAC ratio, post-FUP plasma renin activitiy (PRA), post-SIT PAC, and post-OST urinary aldosterone excretion.
Concordance among confirmatory test results, adverse events in each confirmatory test, and clinical characteristics of test-positive patients among confirmatory tests are also analyzed.
Management information
Registered date
| 2019 | Year | 07 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042530
