Primary Aldosteronism In Hypertensive Patients in China

Study Overview
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Brief Summary
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To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension.

Detailed Description
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This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai, Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. This study will be completed in two years.

Official Title
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Primary Aldosteronism In Hypertensive Patients in China

Conditions
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Hyperaldosteronism; Primary, Hypertension Secondary

Intervention / Treatment
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* Diagnostic Test: Aldosterone/renin ratio (ARR) testing
* Diagnostic Test: Confirmatory tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed hypertension(with a course less than six months); Drug negative, or voluntary to discontinue/change the anti-hypertensive medications; Aged between 18-80 year, gender is not limited; Voluntary to sign on the informed consent. Exclusion Criteria: patients with severe cardiac, hepatic or renal dysfunction; suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without primary aldosteronism (PA)<br>PA case detection or confirmatory tests was negative. | Diagnostic Test: Aldosterone/renin ratio (ARR) testing<br>* Plasma aldosterone concentration tests, Direct renin concentration tests<br>|
| Patients with primary aldosteronism (PA)<br>PA case detection and confirmatory tests were positive. | Diagnostic Test: Aldosterone/renin ratio (ARR) testing<br>* Plasma aldosterone concentration tests, Direct renin concentration tests<br>Diagnostic Test: Confirmatory tests<br>* Captopril challenge test, Saline infusion test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with newly diagnosed hypertension | To calculate the prevalence of PA in Chinese patients with hypertension | 2 years | 
| Number of subjects with confirmed primary aldosteronism (PA) | To calculate the prevalence of PA in Chinese patients with hypertension | 2 years | 
| Prevalence of PA | Prevalence of PA= Number of PA / Number of subjects with hypertension | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Characteristics of PA in Chinese patients with hypertension | 2 years | 
| Blood pressure | Characteristics of PA in Chinese patients with hypertension | 2 years | 
| Family history of hypertension | Characteristics of PA in Chinese patients with hypertension | 2 years | 
| Fasting blood glucose | Characteristics of PA in Chinese patients with hypertension | 2 years | 
| Cardiovascular events | Characteristics of PA in Chinese patients with hypertension | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevalence, primary aldosteronism, hypertension, nationwide