Clinical trial NCT03155139: Primary Aldosteronism In Hypertensive Patients in China
Official title: Primary Aldosteronism In Hypertensive Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperaldosteronism; Primary
Hypertension Secondary
Keywords: prevalence
primary aldosteronism
hypertension
nationwide
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
First posted: 2017-05-16
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with newly diagnosed hypertension
timeFrame: 2 years
measure: Number of subjects with confirmed primary aldosteronism (PA)
timeFrame: 2 years
measure: Prevalence of PA
timeFrame: 2 years
Secondary outcomes:
measure: Age
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: Family history of hypertension
timeFrame: 2 years
measure: Fasting blood glucose
timeFrame: 2 years
measure: Cardiovascular events
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China
name: Jun Cai, phD
role: PRINCIPAL_INVESTIGATOR
References:
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):1470320316657450. doi: 10.1177/1470320316657450. Print 2016 Jul.
citation: 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.
citation: 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.
citation: 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.