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临床试验/NCT07111351
NCT07111351招募中不适用

Multi-omics Studies of Primary Aldosteronism

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Multi-omics data and analysis results

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Multi-omics data and analysis results

时间窗: May 2025 to May 2029

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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