UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015117 |
|---|---|
| Receipt number | R000017583 |
| Scientific Title | Investigations of actual conditions and diagnostic values of adrenal vein sampling in primary aldosteronism |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2018/03/15 13:07:27 |
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Basic information
Public title
Investigations of actual conditions and diagnostic values of adrenal vein sampling in primary aldosteronism
Acronym
WAVES
Scientific Title
Investigations of actual conditions and diagnostic values of adrenal vein sampling in primary aldosteronism
Scientific Title:Acronym
WAVES
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Endocrine surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual conditions and diagnostic values of adrenal vein sampling (AVS) as subtype testing in primary aldosteronism (PA)
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of AVS. Proportions of unilateral PA. Percentages of operation.
Key secondary outcomes
Proportions of changes of subtype diagnosis before and after ACTH stimulation. Postoperative outcome of blood pressure, serum potassium, plasma aldosterone concentration, and renin activity.
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
1. Patients with PA subjected to AVS at Kyoto Medical Center and collaborative centers between January 2006 and December 2013.
2. All patients were diagnosed as PA according to the guidelines of the Japan Endocrine Society and the Japanese Society of Hypertension.
Key exclusion criteria
Patients who were decided not to be eligible for the study by the attending doctors.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhide Naruse |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Division of Endocrinology, Metabolism, and Hypertension Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address
1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL
075-641-9161
mnaruse@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhide Naruse |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Division of Endocrinology, Metabolism, and Hypertension Clinical Research Institute for Endocrine an
Zip code
Address
1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto 612-8555, Japan
TEL
075-641-9161
Homepage URL
mnaruse@kyotolan.hosp.go.jp
Sponsor or person
Institute
NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO Kyoto Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立病院機構京都医療センター(京都)
明石医療センター(兵庫）
三田市民病院(兵庫）
広島鉄道病院(広島）
松山赤十字病院(愛媛）
済生会富田林病院(大阪）
国立病院機構九州医療センター(福岡）
市立札幌病院(北海道）
済生会横浜東部病院 (神奈川）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, observation study.
Management information
Registered date
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
