Multi-omics Studies of Primary Aldosteronism

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Without intervention

    Other intervention

    Without intervention

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Aldosterone-producing adenoma1 intervention
Group B: Idiopathic hyperaldosteronism1 intervention
Group C: Primary Hpertension1 intervention
Group D: Health control1 intervention

Trial outcomes

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.

Time frame
May 2025 to May 2029

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.