UMIN-CTR Clinical Trial

Basic information
Public title	Clinical characteristics of primary aldosteronism and differences between primary aldosteronism and essential hypertension
Acronym	Clinical characteristics of primary aldosteronism and differences between primary aldosteronism and essential hypertension
Scientific Title	Clinical characteristics of primary aldosteronism and differences between primary aldosteronism and essential hypertension
Scientific Title:Acronym	Clinical characteristics of primary aldosteronism and differences between primary aldosteronism and essential hypertension
Region	Japan

Condition
Condition	Primary aldosteronism
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	There are several types of primary aldosteronism, each with different clinical characteristics. The objective of this study is to clarify the clinical characteristics of each type of primary aldosteronism and the differences between primary aldosteronism and essential hypertension.
Basic objectives2	Others
Basic objectives -Others	Measurement of proteins and non-coding RNAs presumed to be involved in primary aldosteronism using stored samples
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	age, gender, blood pressure, BMI, blood tests (Serum biochemistry test, Daily fluctuation of hormones, etc.), urinalysis, confirmatory tests(captopril challenge test, furosemide and upright posture test, saline infusion test), contrast CT examination, adrenal vein sampling, Portable polysomnography
Key secondary outcomes	protein and non-coding RNA presumed to be involved in primary aldosteronism

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	Patients who were diagnosed with primary aldosteronism and essential hypertention(January, 2006-March, 2024)
Key exclusion criteria	Not applicable
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Abe
Organization	Nihon University School of Medicine
Division name	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code	173-8610
Address	30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL	+81-3-3972-8111
Email	abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kobayashi
Organization	Nihon University School of Medicine
Division name	Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code	173-8610
Address	30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL	+81-3-3972-8111
Homepage URL
Email	kobayashi.hiroki@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

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)

IRB Contact (For public release)
Organization	Nihon university Itabashi hospital clinical reseach center
Address	30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
Tel	+81-3-3972-8111
Email	med.itabashi.chiken@nihon-u.ac.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 28 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 24 Day
Date of IRB	2020 Year 04 Month 24 Day
Anticipated trial start date	2020 Year 04 Month 28 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	age, gender, blood pressure, BMI, blood tests (Serum biochemistry test, Daily fluctuation of hormones, etc.), urinalysis, confirmatory tests(captopril challenge test, furosemide and upright posture test, saline infusion test), contrast CT examination, adrenal vein sampling, Portable polysomnography,Protein and non-coding RNA presumed to be involved in primary aldosteronism,etc.

Management information
Registered date	2020 Year 04 Month 28 Day
Last modified on	2020 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045703