Primary Aldosteronism In Hypertensive Patients in China

NCT ID: NCT03155139

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-03

Study Completion Date

2018-11-30

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.

Conditions

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Hyperaldosteronism; Primary Hypertension Secondary

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients without primary aldosteronism (PA)

PA case detection or confirmatory tests was negative.

Aldosterone/renin ratio (ARR) testing

Intervention Type DIAGNOSTIC_TEST

Plasma aldosterone concentration tests, Direct renin concentration tests

Patients with primary aldosteronism (PA)

PA case detection and confirmatory tests were positive.

Aldosterone/renin ratio (ARR) testing

Intervention Type DIAGNOSTIC_TEST

Plasma aldosterone concentration tests, Direct renin concentration tests

Confirmatory tests

Intervention Type DIAGNOSTIC_TEST

Captopril challenge test, Saline infusion test

Interventions

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Aldosterone/renin ratio (ARR) testing

Plasma aldosterone concentration tests, Direct renin concentration tests

Intervention Type DIAGNOSTIC_TEST

Confirmatory tests

Captopril challenge test, Saline infusion test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role collaborator

Qifu Li

OTHER

Sponsor Role lead

Responsible Party

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Qifu Li

Primary Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun Cai, phD

Role: PRINCIPAL_INVESTIGATOR

Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China

Locations

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 27534428 (View on PubMed)

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.

Reference Type RESULT
PMID: 26934393 (View on PubMed)

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.

Reference Type RESULT
PMID: 27172433 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32327102 (View on PubMed)

Other Identifiers

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PA-China 2017

Identifier Type: -

Identifier Source: org_study_id

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