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The Association Between Primary Aldosteronism and Cognitive Dysfunction

NCT ID: NCT07304674

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2031-12-31

Brief Summary

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The goal of this observational study is to learn about the prevalence, progression, and influencing factors of cognitive impairment in patients with primary aldosteronism (PA). The main questions it aims to answer are:

1. What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it?
2. What is the incidence of cognitive progression in PA patients within 1 and 5 years of follow-up and what factors influence this progression? Participants who are already diagnosed with PA as part of their regular medical care will be invited to join this long-term study. They will complete regular cognitive tests, medical check-ups, and questionnaires for up to 5 years. Some participants will also have optional blood tests and brain scans to help researchers understand the causes behind any cognitive changes.

Detailed Description

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This is a prospective observational cohort study conducted in two tertiary hospitals. The main purposes are to investigate the prevalence and influencing factors of baseline cognitive impairment (including mild cognitive impairment \[MCI\] and dementia) in patients with primary aldosteronism (PA), assess the incidence and influencing factors of cognitive progression within 1 and 5 years of follow-up, and compare exploratory biomarkers (e.g., plasma neurofilament light chain \[NfL\] and brain MRI measures) between PA patients with and without baseline cognitive impairment. Eligible patients will be followed up for 5 years, with regular cognitive function assessment, clinical indicator monitoring, and detection of relevant biomarkers and imaging indicators. The study aims to delineate the cognitive trajectory in PA and identify associated clinical and biological predictors.

Conditions

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Primary Aldosteronism Cognitive Dysfunction Mild Cognitive Impairment (MCI) Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 1\. Aged ≥ 40 years.
* 2\. Biochemically confirmed diagnosis of Primary Aldosteronism (PA) according to contemporary guidelines (e.g., confirmed positive case detection test and confirmatory test).
* 3\. Ability to understand and cooperate with comprehensive neuropsychological assessment.
* 4\. Voluntary participation and provision of written informed consent.

Exclusion Criteria

* 1\. Significant visual, hearing, or motor impairment that prevents completion of cognitive testing.
* 2\. History of major neurological disorders (e.g., stroke, Parkinson's disease, intracranial tumor, severe traumatic brain injury).
* 3\. History of major psychiatric illness, intellectual disability, or current use of antipsychotic medications.
* 4\. Diagnosis of secondary hypertension other than PA.
* 5\. Unwillingness to participate by the patient or their legal representative.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinjiang Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiang Xie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiang Xie, PhD

Role: STUDY_CHAIR

First Affiliated Hospital of Xinjiang Medical University

Locations

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The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Site Status

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Countries

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China

Central Contacts

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Xiang Xie, PhD

Role: CONTACT

Phone: +86-991-4366892

Email: [email protected]

Kaige Feng

Role: CONTACT

Phone: +86-17828098050

Email: [email protected]

Facility Contacts

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peijian wang, PhD

Role: primary

xiang xie, PhD

Role: primary

Kaige Feng

Role: backup

Other Identifiers

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K202511-02

Identifier Type: -

Identifier Source: org_study_id