Unique ID issued by UMIN | UMIN000000998 |
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Receipt number | R000001201 |
Scientific Title | Primary Hyperaldosteronism in Japan |
Date of disclosure of the study information | 2008/02/01 |
Last modified on | 2008/07/28 12:26:18 |
Primary Hyperaldosteronism in Japan
PHAS-J
Primary Hyperaldosteronism in Japan
PHAS-J
Japan |
hypertension
Medicine in general | Cardiology | Endocrinology and Metabolism |
Nephrology | Neurology | Endocrine surgery |
Urology |
Others
NO
The aim of the study is to elucidate the prevalence of primary aldosteronism in patients with hypertension in Japan
Others
Prevalence
Confirmatory
Pragmatic
Not applicable
Prevalence of primary aldosteronism in patients with hypertension in Japan
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.
Observational
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
3500
1st name | |
Middle name | |
Last name | Mitsuhide Naruse |
National Hospital Organization, Kyoto Medical Center
Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
1-1 Fukakusa, Mukaihata-cho, Fushimiku, Kyoto, Japan
075-641-9161
1st name | |
Middle name | |
Last name | Mitsuhide Naruse |
National Hospital Organization, Kyoto Medical Center
Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
1-1 Fukakusa, Mukaihata-cho, Fushimiku, Kyoto, Japan
075-641-9161
http://poppy.ac/nho/img/summary/phasj_gaiyou.html
mnaruse@kyotolan.hosp.go.jp
National Hospital Organization
National Hospital Organization
Japan
Cooperative research group for PHAS-J Study of National Hospital Organization
NO
2008 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2005 | Year | 05 | Month | 12 | Day |
2005 | Year | 06 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
2008 | Year | 04 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
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
2008 | Year | 01 | Month | 28 | Day |
2008 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001201
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