Primary Aldosteronism In Hypertensive Patients in China

Completed

• Conditions: Hyperaldosteronism; Primary; Hypertension Secondary
• Interventions: Diagnostic Test: Aldosterone/renin ratio (ARR) testing; Diagnostic Test: Confirmatory tests

• Registration Number: NCT03155139
• Lead Sponsor: Qifu Li

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-13
• Study First Posted: 2017-05-16
• Study Start: 2017-06-03
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

1. Newly diagnosed hypertension(with a course less than six months);
2. Drug negative, or voluntary to discontinue/change the anti-hypertensive medications;
3. Aged between 18-80 year, gender is not limited;
4. Voluntary to sign on the informed consent.

Exclusion Criteria

1. patients with severe cardiac, hepatic or renal dysfunction;
2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without primary aldosteronism (PA)	Aldosterone/renin ratio (ARR) testing	PA case detection or confirmatory tests was negative.
Patients with primary aldosteronism (PA)	Aldosterone/renin ratio (ARR) testing	PA case detection and confirmatory tests were positive.
Patients with primary aldosteronism (PA)	Confirmatory tests	PA case detection and confirmatory tests were positive.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China