UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022466 |
|---|---|
| Receipt number | R000025889 |
| Scientific Title | Clinical characteristics of primary aldosteronism |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2016/05/26 12:08:03 |
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Basic information
Public title
Clinical characteristics of primary aldosteronism
Acronym
Clinical characteristics of primary aldosteronism
Scientific Title
Clinical characteristics of primary aldosteronism
Scientific Title:Acronym
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
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 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
| 1st name | |
| Middle name | |
| Last name | Haketa Akira |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610
TEL
+81-3-3972-8111
haketa.akira@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haketa Akira |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo 173-8610
TEL
+81-3-3972-8111
Homepage URL
haketa.akira@nihon-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
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
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025889
