Chongqing Primary Aldosteronism Study

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Other: no intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Shumin Yang, phD; Phone Number: +86 023-89011552; Email: 443068494@qq.com
• Study Contact Backup: Name: Qifu Li, PhD; Phone Number: +86 023-89011552; Email: liqifu@yeah.net

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • Qifu Li
      • Contact: Qifu Li, PhD; Phone Number: +86 23 89011552; Email: liqifu@yeah.net

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

hypertensive patients who completed ARR screening and necessary further tests and Voluntary to be followed up will be included.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary aldosteronism; screened, confirmed and subtyped according to the guidelines.	Other: no intervention; no intervention
Essential hypertension; screened for PA and excluded the diagnosis of PA as well as other secondary hypertesion	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated glomerular filtration rate (eGFR)	Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)	1-15 years
The incidence of new atrial fibrillation	Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension	1-15 years
The incidence of left ventricular hypertrophy	Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension	1-15 years
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
subgroup analysis of cardiovascular events	Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia	1-15 years
quality of life score	Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.	1-15 years
Cardiovascular risk score	To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA	1-15 years

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Study Chair: Qifu Li, phD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Yang Y, Williams TA, Song Y, Yang S, He W, Wang K, Cheng Q, Ma L, Luo T, Yang J, Reincke M, Burrello J, Li Q, Mulatero P, Hu J. Nomogram-Based Preoperative Score for Predicting Clinical Outcome in Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa634. doi: 10.1210/clinem/dgaa634.
• Wang K, Hu J, Yang J, Song Y, Fuller PJ, Hashimura H, He W, Feng Z, Cheng Q, Du Z, Wang Z, Ma L, Yang S, Li Q. Development and Validation of Criteria for Sparing Confirmatory Tests in Diagnosing Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa282. doi: 10.1210/clinem/dgaa282.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular events; Primary aldosteronism; cerebrovascular events
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: CONPASS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No