Primary Aldosteronism In Hypertensive Patients in China (PA-China)

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

Study Overview

• Status: Completed
• Conditions: Hyperaldosteronism; Primary; Hypertension Secondary
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 3500

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sampling Design: hypertensive patients will be continuously sampled for case detection in each center. PASS 11.0 Software-Confidence Intervals for One Proportion was used to calculate the sample size. A sample size of 2928 produces a two-sided 95% confidence interval with a width equal to 0.02 when the sample proportion(prevalence of PA) is 0.080. Accounting for the 20% withdraw rate in the process of case detection, the final sample size should be 3635 (about 4000 cases).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qifu Li
• Collaborators: Fu Wai Hospital, Beijing, China
• Investigators: Principal Investigator: Jun Cai, phD, Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China

Publications and helpful links

General Publications

• 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):1470320316657450. doi: 10.1177/1470320316657450. Print 2016 Jul.
• 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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
• Kayser 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 Endocrinol Metab. 2016 Jul;101(7):2826-35. doi: 10.1210/jc.2016-1472. Epub 2016 May 12.
• Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 13, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; prevalence; primary aldosteronism; nationwide
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hypertension; Hyperaldosteronism
• Other Study ID Numbers: PA-China 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No