Primary Aldosteronism In Hypertensive Patients in China

Hypertension Secondary Clinical Trial

— PA-China  

Official title:

Primary Aldosteronism In Hypertensive Patients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155139
• Other study ID #: PA-China 2017
• Status: Completed
• Start date: June 3, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hyperaldosteronism; Primary
• Hypertension
• Hypertension Secondary

Intervention

Diagnostic Test:
• Aldosterone/renin ratio (ARR) testing
Plasma aldosterone concentration tests, Direct renin concentration tests
• Confirmatory tests
Captopril challenge test, Saline infusion test

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Qifu Li	Fu Wai Hospital, Beijing, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 Ma — View Citation

Käyser SC, Dekkers T, Groenewoud HJ, van der Wilt GJ, Carel Bakx J, van der Wel MC, Hermus AR, Lenders JW, Deinum J. Study Heterogeneity and Estimation of Prevalence of Primary Aldosteronism: A Systematic Review and Meta-Regression Analysis. J Clin Endocr — View Citation

Li X, Goswami R, Yang S, Li Q. Aldosterone/direct renin concentration ratio as a screening test for primary aldosteronism: A meta-analysis. J Renin Angiotensin Aldosterone Syst. 2016 Aug 17;17(3). pii: 1470320316657450. doi: 10.1177/1470320316657450. Prin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with newly diagnosed hypertension	To calculate the prevalence of PA in Chinese patients with hypertension	2 years
Primary	Number of subjects with confirmed primary aldosteronism (PA)	To calculate the prevalence of PA in Chinese patients with hypertension	2 years
Primary	Prevalence of PA	Prevalence of PA= Number of PA / Number of subjects with hypertension	2 years
Secondary	Age	Characteristics of PA in Chinese patients with hypertension	2 years
Secondary	Blood pressure	Characteristics of PA in Chinese patients with hypertension	2 years
Secondary	Family history of hypertension	Characteristics of PA in Chinese patients with hypertension	2 years
Secondary	Fasting blood glucose	Characteristics of PA in Chinese patients with hypertension	2 years
Secondary	Cardiovascular events	Characteristics of PA in Chinese patients with hypertension	2 years