Clinical trial NCT06597630: Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism
Official title: Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism，A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Keywords: Pathological type
Gene mutation
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, about 100 patients with unilateral protonaldehydes undergoing total adrenal resection will be continuously enrolled in this research center from December 2023.

Unilateral Primary Aldosteronism underwent total Adrenalectomy were continuously included

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.

Eligibility criteria: 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

Primary outcomes:
measure: Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
timeFrame: 2 weeks after surgery
measure: The proportion with genetic mutations
timeFrame: 2 weeks after surgery
measure: Analyze the Aldosterone level and renin level Characteristics
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions
timeFrame: 2 weeks after surgery
measure: Analyze the blood potassium and blood pressure Characteristics
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qifu Li, PhD
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Li Qifu
role: STUDY_CHAIR
References:
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