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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000998
Receipt No. R000001201
Scientific Title Primary Hyperaldosteronism in Japan
Date of disclosure of the study information 2008/02/01
Last modified on 2008/07/28

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Basic information
Public title Primary Hyperaldosteronism in Japan
Acronym PHAS-J
Scientific Title Primary Hyperaldosteronism in Japan
Scientific Title:Acronym PHAS-J
Region
Japan

Condition
Condition hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Neurology Endocrine surgery
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to elucidate the prevalence of primary aldosteronism in patients with hypertension in Japan
Basic objectives2 Others
Basic objectives -Others Prevalence
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of primary aldosteronism in patients with hypertension in Japan
Key secondary outcomes Secondary outcomes are to establish the importance of investigating the cause of hypertension in clinical practice and to spread the standard medical practice specific to the cause of hypertension.

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
75 years-old >=
Gender Male and Female
Key inclusion criteria Hypertensive patients in the outpatient clinic and hospital, who full-fill the following 1) or 2) criteria:
1)treated hypertensive patients
2)untreated hypertensive patients with systolic blood pressure higher than 140mmHg or diastolic blood pressure higher than 90mmHg according to the guideline of the Japan Society of Hypertension.
Key exclusion criteria 1)pregnant patients
2)patients taking diuretics or aldosterone antagonist
3)patients with the following diseases:
(1)secondary hypertension (renal hypertension,renovascular hypertension, primary aldosteronism, Cushing's syndrome, pheochromocytoma, iatrogenic diseases etc)
(2)patients whom the attending doctors decides not suitable for the entry because of the unstable stage of the following complications: coronary diseases, arrhythmia, severe valvular diseases, cerebrovascular diseases, acute and chronic renal failure (serum Cr higher than 3mg/dl), acute and chronic liver diseases
(3)orthostatic hypotension
4) Patients whom the attending doctor decides not suitable for the entry of the study.
Target sample size 3500

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 Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa, Mukaihata-cho, Fushimiku, Kyoto, Japan
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa, Mukaihata-cho, Fushimiku, Kyoto, Japan
TEL 075-641-9161
Homepage URL http://poppy.ac/nho/img/summary/phasj_gaiyou.html
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Cooperative research group for PHAS-J Study of National Hospital Organization
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

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 01 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
2005 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 05 Month 01 Day
Date analysis concluded
2008 Year 09 Month 01 Day

Other
Other related information 1. Study protocol
1) Obtaining informed consent
2) First blood sampling for Na, K, Cl, BUN, Cr, UA, plasma aldosterone, PRA, adrenalin, and noradrenalin.
3) Second blood sampling under more restricted conditions. If at least one time of the results of PAC and PRA full-fills the criteria (PAC more than 12ng/dl and PRA less than 1.0ng/ml/h and PAC/PRA more than 20), patients are diagnosed as suspicion of PA. If not, patients are diagnosed as ther type of hypertension.
4) Adrenal CT (MRI): (1) unilateral macroadenoma (larger than 1 cm): at least one of the confirmatory tests is performed. Patients are diagnosed as aldosterone-producing adenoma (APA) (macroadenoma) if positive test and as non-functioning adenoma if negative test, respectively. Adrenal scintigraphy and/or adrenal sampling is considered if necessarily. (2) No obvious tumor or bilateral: steps 5) and 6) are mandatory.
5) Furosemide-upright test: Patients are diagnosed as other type of hypertension if PRA is more than 1ng/ml/h.
6) Adrenal scintigraphy and/or adrenal venous sampling: These tests are indicated in patients with PRA less than 1ng/ml/h on furosemide-upright test and patients in whom the test was not performed. Patients are diagnosed as APA (microadenoma) if there is a significant laterality, IHA if bilateral, and other type of hypertension in others.
7) Confirmatory tests: if none of the tests of 5) and 6) is performed, at least one of the confirmatory tests is mandatory. Patients are diagnosed as PA if positive test, other type of hypertension if negative test, and suspicion of PA if the test not performed, respectively.
2. Determinants
1) age, gender, duration of hypertension, history, life style, medications, symptom, 2) height, weight, blood pressure, pulse rate, 3) blood tests, 4) adrenal CT (MRI), 5) Furosemide-upright test, 6) confirmatory tests, 7) adrenal scintigraphy, 8) adrenal sampling

Management information
Registered date
2008 Year 01 Month 28 Day
Last modified on
2008 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001201

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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