Multi-omics Studies of Primary Aldosteronism

NCT ID: NCT07111351

Last Updated: 2025-12-09

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

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-15

Study Completion Date

2029-05-31

Brief Summary

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Primary aldosteronism is a prevalent yet underdiagnosed cause of secondary hypertension, contributing to significant cardiovascular morbidity and renal dysfunction. Despite affecting up to 20% of hypertensive patients, PA is frequently missed because it lacks distinctive clinical features and often presents with nonspecific symptoms like resistant hypertension or subtle electrolyte imbalances. The diagnostic pathway involves a stepwise approach: initial screening via the aldosterone-to-renin ratio, confirmatory testing (e.g., saline suppression or captopril challenge), and subtype differentiation using adrenal venous sampling to distinguish unilateral adenoma from bilateral hyperplasia. This complexity, combined with clinician unfamiliarity and variable access to specialized centers, perpetuates underdiagnosis. Early identification and tailored treatment are paramount in improving outcomes for patients with primary aldosteronism.

In this study, we will conduct a comprehensive multi-omics analysis on three sample types: 1) blood and urine samples from patients with primary aldosteronism, primary hypertension, and healthy controls; and 2) adrenal tissue samples from patients undergoing adrenalectomy for aldosterone-producing adenomas. We aim to systematically identify differentially expressed biomarkers that could serve as potential early diagnostic markers for primary aldosteronism. The findings may provide new insights into disease pathogenesis and contribute to improving early detection and personalized treatment strategies for this condition.

Detailed Description

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Conditions

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Primary Aldosteronism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aldosterone-producing adenoma

Without intervention

Intervention Type OTHER

Without intervention

Idiopathic hyperaldosteronism

Without intervention

Intervention Type OTHER

Without intervention

Primary Hpertension

Without intervention

Intervention Type OTHER

Without intervention

Health control

Without intervention

Intervention Type OTHER

Without intervention

Interventions

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Without intervention

Without intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with primary aldosteronism , primary hypertension , or age- and sex-matched healthy controls;
2. Aged 18-80 years with complete medical records;
3. Willing to participate voluntarily and provide informed consent.

Exclusion Criteria

1. History of chemotherapy or radiotherapy in the adrenal region ;
2. Positive serological or nucleic acid test results for HIV, hepatitis B, or hepatitis C , or a prior confirmed diagnosis;
3. Individuals with malignancies or autoimmune disorders ;
4. Study withdrawal during the trial period
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wencong Han

Role: CONTACT

+8618863665375

Facility Contacts

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Zheng Zhang

Role: primary

+8613901371490

Other Identifiers

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2025R0135

Identifier Type: -

Identifier Source: org_study_id

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