PA-China: Primary Aldosteronism In Hypertensive Patients in China

Sponsor

Qifu Li (Other)

Overall Status

Completed

CT.gov ID

NCT03155139

Collaborator

Fu Wai Hospital, Beijing, China (Other)

3,500

Enrollment

Location

17.9

Actual Duration (Months)

195.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperaldosteronism; Primary Hypertension Secondary	Diagnostic Test: Aldosterone/renin ratio (ARR) testing Diagnostic Test: Confirmatory tests

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3500 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Primary Aldosteronism In Hypertensive Patients in China

Actual Study Start Date :

Jun 3, 2017

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Nov 30, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Patients without primary aldosteronism (PA)

PA case detection or confirmatory tests was negative.

Diagnostic Test: Aldosterone/renin ratio (ARR) testing

Plasma aldosterone concentration tests, Direct renin concentration tests

Patients with primary aldosteronism (PA)

PA case detection and confirmatory tests were positive.

Diagnostic Test: Aldosterone/renin ratio (ARR) testing

Plasma aldosterone concentration tests, Direct renin concentration tests

Diagnostic Test: Confirmatory tests

Captopril challenge test, Saline infusion test

Outcome Measures

Primary Outcome Measures

Number of subjects with newly diagnosed hypertension [2 years]
To calculate the prevalence of PA in Chinese patients with hypertension
Number of subjects with confirmed primary aldosteronism (PA) [2 years]
To calculate the prevalence of PA in Chinese patients with hypertension
Prevalence of PA [2 years]
Prevalence of PA= Number of PA / Number of subjects with hypertension

Secondary Outcome Measures

Age [2 years]
Characteristics of PA in Chinese patients with hypertension
Blood pressure [2 years]
Characteristics of PA in Chinese patients with hypertension
Family history of hypertension [2 years]
Characteristics of PA in Chinese patients with hypertension
Fasting blood glucose [2 years]
Characteristics of PA in Chinese patients with hypertension
Cardiovascular events [2 years]
Characteristics of PA in Chinese patients with hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.