UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical significance of plasma aldosterone concentration in patients with primary aldosteronism
Title of the study (Brief title)	Clinical significance of plasma aldosterone concentration in patients with 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 purpose of this study is to clarify clinical significance of Primary aldosteronism whose plasma aldosterone concentration is within normal level.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical features and Cardio- and cerebro-vascular events
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who has diagnosed primary aldosteronism between January 2004 and December 2015 Patients who has diagnosed essential hypertension between January 2004 and December 2013
Key exclusion criteria	Non
Target sample size	750

Research contact person
Name of lead principal investigator	Tetsuhiro Kitamura
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
Address	2-2 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3742
Email	tkitamura@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	Tetsuhiro Kitamura
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
Address	2-2 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3742
Homepage URL
Email	tkitamura@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Department of Metabolic Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Metabolic Medicine, Osaka University Graduate School of Medicine
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	西宮市立中央病院　内科（兵庫県） 関西労災病院　内科（兵庫県） NTT西日本大阪病院　内分泌代謝内科（大阪府） 国立病院機構 大阪南医療センター　内分泌代謝内科（大阪府） 千里中央クリニック（大阪府） 中尾内科クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 13 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	The patients data, such as age, gender, body mass index, systolic blood pressure, diastolic blood pressure, number of antihypertensive classes, age of hypertension onset, duration of hypertension, cardiovascular risk factors and complications of CCV events were collected from medical records.

Management information
Registered date	2015 Year 01 Month 13 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018797