An observational study in Primary Aldosteronism, sponsored by Qifu Li. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Qifu Li · Observational
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.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Qifu Li is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The patient was diagnosed with unilateral primary aldosteronism and underwent total adrenal resection
Other: Tissue specimens were stained by histopathology of hematoxylin-eosin
Whole 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
Also known as: Tissue specimens were stained by CYP11B2
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 surgery
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 surgery
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 surgery
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 surgery
Analyze the blood potassium and blood pressure Characteristics
Primary aldosterone has varying degrees of hypertension with or without hypokalemia
Time frame: 2 weeks after surgery
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Oct 2024, 10 months after the start.
Of 64 non-industry observational studies under Hyperaldosteronism, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 96. This study's planned 10 months is below that.
Counting every sponsor, half of 64 studies reached it within 75 months; a quarter within 32 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Qifu Li