Chongqing Primary Aldosteronism Study

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Other: no intervention

• Registration Number: NCT03224312
• Lead Sponsor: Chongqing Medical University

Brief 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.

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 Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
numbers of patients who develop cardiovascular events	1-15 years	compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Qifu Li; 🇨🇳 Chongqing, Chongqing, China