Multi-omics Studies of Primary Aldosteronism

NCT07111351 | Recruiting

• 1 other identifier: 2025R0135
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• Multi-omics data and analysis results

  Collect various types of biological samples and utilize advanced proteomics and metabolomics technologies to obtain comprehensive omics data. Based on this, combine machine learning algorithms to deeply mine multi-omics data and clinical information, aiming to screen novel biomarkers for the prediction, classification, and diagnosis of primary aldosteronism, and construct a high-precision prediction model.

  May 2025 to May 2029

Study Arms (4)

Aldosterone-producing adenoma

Other: Without intervention

Idiopathic hyperaldosteronism

Other: Without intervention

Primary Hpertension

Other: Without intervention

Health control

Other: Without intervention

Interventions

Without intervention OTHER

Without intervention

Aldosterone-producing adenoma; Health control; Idiopathic hyperaldosteronism; Primary Hpertension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants recruited at Peking University First Hospital from May 2025 to May 2029. Eligible participants must meet all inclusion criteria: (1) diagnosis of primary aldosteronism, primary hypertension, or being age- and sex-matched healthy controls; (2) aged 18-80 years with complete medical records; and (3) voluntary participation with informed consent provision. Exclusion criteria include: (1) history of adrenal region chemotherapy/radiotherapy; (2) positive HIV/hepatitis B/C serology or prior diagnosis; (3) presence of malignancies or autoimmune disorders; and (4) withdrawal during the trial period. The study plans to enroll 400 patients.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Methods

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Wencong Han

CONTACT

+8618863665375; hanwencong163@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)