UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical characteristics of primary aldosteronism
Title of the study (Brief title)	Clinical characteristics of primary aldosteronism
Region	Japan

Condition
Condition	Primary aldosteronism Essential hypertension
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to confirm the clinical characteristics between primary aldosteronism.
Basic objectives2	Others
Basic objectives -Others	The objective of this study is to compare the differences in circadian variation of serum adrenocortical hormone levels, 24-h urinary aldosterone level, visceral adipose tissue, and subcutaneous adipose tissue in unilateral hyperaldosteronism(UHA) and bilateral hyperaldosteronism(BHA), and assess the clinical characteristics between UHA and BHA.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Circadian variation of adrenocortical hormones 24-h Urinary Aldosterone Visceral fat tissue Subcutaneous fat tissue Subtype of primary aldosteronism
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

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	Patients who were diagnosed with primary aldosteronism and performed adrenal venous sampling. Patients who was diagnosed with essential hypertension (January, 2006-Octobar, 2015).
Key exclusion criteria	Not applicable
Target sample size	157

Research contact person
Name of lead principal investigator	Haketa Akira
Organization	Nihon University School of Medicine
Division name	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Address	30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610
TEL	+81-3-3972-8111
Email	haketa.akira@nihon-u.ac.jp

Public contact
Name of contact person	Haketa Akira
Organization	Nihon University School of Medicine
Division name	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Address	30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610
TEL	+81-3-3972-8111
Homepage URL
Email	haketa.akira@nihon-u.ac.jp

Sponsor
Institute	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
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	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 22 Day
Anticipated trial start date	2015 Year 10 Month 22 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	Partially published
URL releasing results
Results
Other related information	The baseline plasma aldosterone concentration (PAC) and 24-h urinary aldosterone level in patients with unilateral hyperaldosteronism was significantly higher than that in patients with bilateral hyperaldosteronism, particularly at 6:00.

Management information
Registered date	2016 Year 05 Month 26 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025889