UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigations of actual conditions and diagnostic values of adrenal vein sampling in primary aldosteronism
Title of the study (Brief title)	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	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
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	Mitsuhide Naruse
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Division of Endocrinology, Metabolism, and Hypertension Clinical Research Institute for Endocrine an
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017583