UMIN-CTR Clinical Trial

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	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
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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