Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism
ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorQifu Li
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No gender limitation;
Age 18-80 years old;
The patient was diagnosed with UPA and underwent total adrenal resection.
Disqualifiers
Bilateral disease
Partial of no biochemical response in follow-up
partial adrenalectomy
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tissue specimens were stained by histopathology of hematoxylin-eosin
Other interventionWhole slide images were created by scanning the complete histologic slide to produce high-resolution digital files of the histopathology of hematoxylin-eosin and CYP11B2 immunostained sections.Tissue sections of all blocks from each resected adrenal were evaluated by hematoxylin and eosin and CYP11B2 immunostaining and adrenal specimens were categorized as classical or nonclassical histopathologic findings of unilateral PA according to the HISTALDO consensus; Genotyping was performed using CYP11B2 (aldosterone synthase)-guided sequencing
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: unilateral primary aldosteronism group1 intervention
Trial outcomes
Primary outcomes
1
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Time frame
2 weeks after surgery2
The proportion with genetic mutations
The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Time frame
2 weeks after surgery3
Analyze the Aldosterone level and renin level Characteristics
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
Time frame
2 weeks after surgerySecondary outcomes
1
Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Time frame
2 weeks after surgery2
Analyze the blood potassium and blood pressure Characteristics
Primary aldosterone has varying degrees of hypertension with or without hypokalemia
Time frame
2 weeks after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Qifu Li
Lead sponsor
Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov