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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022657
Receipt No. R000026115
Scientific Title The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Date of disclosure of the study information 2016/06/08
Last modified on 2016/06/08

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Basic information
Public title The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Acronym Useful test and value for determining the subtype of primary aldosteronism
Scientific Title The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Scientific Title:Acronym 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

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 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
1st name
Middle name
Last name Hitoshi Sugihara
Organization Graduate School of Medicine, Nippon Medical School
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
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
1st name
Middle name
Last name AYAKO MORIYA
Organization Graduate School of Medicine, Nippon Medical School
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
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

Other
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

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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