UMIN-CTR Clinical Trial

Basic information
Public title	Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases, Advancing Care of Primary Aldosteronism in Japan Study
Acronym	Japan Primary Aldosteronism Study (JPAS)
Scientific Title	Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases, Advancing Care of Primary Aldosteronism in Japan Study
Scientific Title:Acronym	Japan Primary Aldosteronism Study (JPAS)
Region	Japan

Condition
Condition	Primary Aldosteronsim: PA
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 improve quality of clinical practice of PA and to establish evidence for the clinical guideline of severe form of PA based on 3 clinical questions as followed; 1) prediction score for subtype diagnosis of PA by non-invasive methods,2) standard protocol and decision criteria of adrenal venous sampling(AVS), 3) difference of the effects between surgical and medical treatments of PA, 4)development of highological biomarkers for diagnosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1) baseline informations(age, sex, duration of hypertension, family history, past history, comorbidity, medications, symptoms, height, weight, blood pressure, pulse rate), biochemical data, results of confirmatory testing, CT 2) protocol and decision criteria of AVS 3) effects of surgical and medical treatment of PA 4) post-operative outcomes
Key secondary outcomes	1)Pathological findings 2)Markers of target organ damage:Kidney(eGFR,BUN,Cr),Heart(ECG,CTR) 3)Clinical course(6M,1Y,3Y,5Y):base line informations, Laboratory data 4)Immunohistochemical staining

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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were diagnosed as PA and underwent AVS between January 2006 and Dec 2017 in Kyoto Medical Center and JPAS participating centers
Key exclusion criteria	Patients who were judged not eligible for the study by respective attending physician
Target sample size	3500

Research contact person
Name of lead principal investigator	1st name Naruse Middle name Last name Mitsuhide
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code	612-8555
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL	075-641-9161
Email	japan.pa.registry@gmail.com

Public contact
Name of contact person	1st name Naruse Middle name Last name Mitsuhide
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Clinical Research Institute for Endocrine and Metabolic Disorders
Zip code	612-8555
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL	075-641-9161
Homepage URL	http://portal.e-trial.co.jp/adrenal/
Email	japan.pa.registry@gmail.com

Sponsor
Institute	National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases
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	National Hospital Organization, Kyoto Medical Center
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
Tel	075-641-9161
Email	japan.pa.registry@gmail.com

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) 聖マリアンナ医科大学（神奈川）　　　　　　　 大阪大学（大阪）　　　　　　　　　 大分大学（大分）　　　　　　　　　　　 應義塾大学（東京）　　　　　　　　　　　　 京都大学（京都）　　　　　　　 東京医科歯科大学（東京）　　　　　　　　　　 群馬大学（群馬）　　　　　　　　　　　　 熊本大学（熊本）　　　　　　　　　　　　 東京大学(東京）　　　　　　　　　　　　 金沢大学（金沢）　　　　　　　　 福島県立医科大学（福島）　　　　　 国立国際医療研究センター(東京）　 明石医療センター(兵庫） 三田市民病院(兵庫） JR広島病院(広島） 松山赤十字病院(愛媛） さくら会病院(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） 太田総合病院（福島） 北里大学（神奈川） 鳥取大学（鳥取） 岡崎市民病院（愛知） 天理よろづ病院（奈良） 日本大学（東京） 九州大学病院（福岡） 武蔵野赤十字病院（東京） JCHO九州病院（福岡） 済生会福岡総合病院（福岡）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 25 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	3000
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	No longer recruiting
Date of protocol fixation	2015 Year 05 Month 18 Day
Date of IRB	2015 Year 05 Month 18 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry	2021 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter, observation study.

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2019 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021690