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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040258
Receipt No. R000045703
Scientific Title Clinical characteristics of primary aldosteronism and differences between primary aldosteronism and essential hypertension
Date of disclosure of the study information 2020/04/28
Last modified on 2020/04/28

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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

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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