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Recruitment status Completed
Unique ID issued by UMIN UMIN000015117
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute NHO Kyoto Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017583


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