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UMIN ID:

Recruitment status No longer recruiting
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 2019/07/21

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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
Email 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
Email naohisa-tamura@i.shizuoka-pho.jp

Sponsor
Institute Department of Hypertension Research
Research Support Center
Shizuoka General Hospital
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 142
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 No longer recruiting
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
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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