Primary Aldosteronism In Hypertensive Patients in China

NCT03155139 | Completed DMC

• 1 other identifier: PA-China 2017
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperaldosteronism; Primary; Hypertension Secondary

Keywords

prevalence; primary aldosteronism; hypertension; nationwide

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Age

  2 years

• Blood pressure

  2 years

• Family history of hypertension

  2 years

• Fasting blood glucose

  2 years

• Cardiovascular events

  2 years

Study Arms (2)

Patients without primary aldosteronism (PA)

PA case detection or confirmatory tests was negative.

Diagnostic Test: Aldosterone/renin ratio (ARR) testing

Patients with primary aldosteronism (PA)

PA case detection and confirmatory tests were positive.

Diagnostic Test: Aldosterone/renin ratio (ARR) testing; Diagnostic Test: Confirmatory tests

Interventions

Aldosterone/renin ratio (ARR) testing DIAGNOSTIC_TEST

Plasma aldosterone concentration tests, Direct renin concentration tests

Patients with primary aldosteronism (PA); Patients without primary aldosteronism (PA)

Confirmatory tests DIAGNOSTIC_TEST

Captopril challenge test, Saline infusion test

Patients with primary aldosteronism (PA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qifu Li: lead
• Fu Wai Hospital, Beijing, China: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (4)

• 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.

  PMID: 27534428 RESULT

• 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.

  PMID: 26934393 RESULT

• 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.

  PMID: 27172433 RESULT

• 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.

  PMID: 32327102 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Some subtye of PA such as glucocorticoid remediable aldosteronism(GRA) should be diagnosed by DNA

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jun Cai, phD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 16, 2017
• Study Start: June 3, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)