UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Title of the study (Brief title)	Useful test and value for determining the subtype of 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 diagnostic steps for primary aldosteronism (PA) include case screening tests, confirmatory tests, and localization. The aim of this study was to investigate useful confirmatory tests and their cut-off values for determining the subtype of primary aldosteronism, especially in unilateral PA, such as aldosterone-producing adenoma, and bilateral PA, such as idiopathic hyperaldosteronism.
Basic objectives2	Others
Basic objectives -Others	Adrenal venous sampling (AVS) is the gold-standard test to differentiate unilateral from bilateral disease. However, AVS is far from easy to perform for all patients with PA because of some problems.Therefore, bilateral cases of patients with PA should be identified in a minimally invasive manner before performing AVS.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Investigation of usefulness confirmatory test and value for determining the subtype of primary aldosteronism
Key secondary outcomes

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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
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Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The medical records of patients diagnosed with PA by confirmatory testing and localization by AVS were retrospectively analyzed. Ninety patients admitted to Nippon Medical School Hospital for AVS from January 2009 to March 2015 were examined. The diagnosis was confirmed by endocrinological examinations such as confirmatory tests (CCT, FUT and SIT) and ACTH-stimulated AVS (ACTH-AVS).
Key exclusion criteria	A patient who had iodine allergy and used steroid during AVS Five patients who were diagnosed with subclinical Cushing's syndrome Four patients taking antihypertensive drugs other than calcium channel blockers and a blockers for refractory hypertension One patient with suspected bilateral aldosterone producing adenomas Two patients with unsuccessful AVS One patient who had aldosterone excess and LR over 2.6 on AVS, but CR was over 1.0
Target sample size	76

Research contact person
Name of lead principal investigator	Hitoshi Sugihara
Organization	Graduate School of Medicine, Nippon Medical School
Division name	Department of Endocrinology, Diabetes and Metabolism
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Email	hitoshi@nms.ac.jp

Public contact
Name of contact person	AYAKO MORIYA
Organization	Graduate School of Medicine, Nippon Medical School
Division name	Department of Endocrinology, Diabetes and Metabolism
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	03-3822-2131
Homepage URL
Email	ayako0414@nms.ac.jp

Sponsor
Institute	Graduate School of Medicine, Nippon Medical School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Graduate School of Medicine, Nippon Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 01 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	retrospective review

Management information
Registered date	2016 Year 06 Month 08 Day
Last modified on	2016 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026115