Chongqing Primary Aldosteronism Study

Primary Aldosteronism Clinical Trial

Official title:

Chongqing Primary Aldosteronism Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03224312
• Other study ID #: CONPASS
• Status: Recruiting
• Start date: October 1, 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2023
• Source: Chongqing Medical University
• Contact: Qifu Li, phD
• Phone: +86 023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.

Description:

This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. hypertensive patients who completed ARR screening and necessary further tests;

2. Voluntary to sign 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 et al.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Qifu Li	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052. — View Citation

Stowasser M, Gordon RD. Primary Aldosteronism: Changing Definitions and New Concepts of Physiology and Pathophysiology Both Inside and Outside the Kidney. Physiol Rev. 2016 Oct;96(4):1327-84. doi: 10.1152/physrev.00026.2015. — View Citation

Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of patients who develop cardiovascular events	compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension	1-15 years
Secondary	estimated glomerular filtration rate (eGFR)	Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)	1-15 years
Secondary	The incidence of new atrial fibrillation	Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension	1-15 years
Secondary	The incidence of left ventricular hypertrophy	Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension	1-15 years
Secondary	the variation of carotid intima-media thickness	Compare the occurrence of the variation of carotid intima-media thickness between patients with primary aldosteronism and essential hypertension	1-15 years
Secondary	subgroup analysis of cardiovascular events	Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia	1-15 years
Secondary	quality of life score	Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.	1-15 years
Secondary	Cardiovascular risk score	To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA	1-15 years