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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037304 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Primary Aldosteronism | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Purpose of intervention | |
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Hypertension Research
Research Support Center Shizuoka General Hospital |
Institute | |
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Funding Source | |
Organization | Self funding |
Organization | |
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Category of Funding Organization | Self funding |
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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) |
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Date of disclosure of the study information |
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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. | ||||||
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Recruitment status | Completed | ||||||
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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. |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042530 |
Research Plan | |
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Research case data | |
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