Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Other: Tissue specimens were stained by histopathology of hematoxylin-eosin

• Registration Number: NCT06597630
• Lead Sponsor: Qifu Li

Brief Summary

1. Aim to investigate the pathological feature of UPA in Asians

2. To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians.

3. To explore a new pathological type of unilateral primary aldosterone

Detailed Description

The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. No gender limitation;
2. Age 18-80 years old;
3. The patient was diagnosed with UPA and underwent total adrenal resection.

Exclusion Criteria

1. Bilateral disease
2. Partial of no biochemical response in follow-up
3. partial adrenalectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
unilateral primary aldosteronism group	Tissue specimens were stained by histopathology of hematoxylin-eosin	The patient was diagnosed with unilateral primary aldosteronism and underwent total adrenal resection

Primary Outcome Measures

Name	Time	Method
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions	2 weeks after surgery	Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
The proportion with genetic mutations	2 weeks after surgery	The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Analyze the Aldosterone level and renin level Characteristics	2 weeks after surgery	Aldosterone level（pg/ml）, renin level（uIU/ml）, blood potassium（mmol/L） and blood pressure are the main clinical indicators of primary aldosteronism(Aldosterone level divided by renin level to obtain ARR, ARR greater than 20 consider whether aldosterone autonomic secretion),different pathological types of aldosteronomas were measured to analyze whether there were differences in clinical characteristics of adrenal tumors of different pathological types

Secondary Outcome Measures

Name	Time	Method
Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions	2 weeks after surgery	Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Analyze the blood potassium and blood pressure Characteristics	2 weeks after surgery	Primary aldosterone has varying degrees of hypertension with or without hypokalemia

Trial Locations

Locations (1)

Qifu Li, PhD; 🇨🇳 Chongqing, Chongqing, China