Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma
Conditions
Keywords
1 mg overnight dexamethasone inhibition test, screening
Brief summary
This prospective observational study evaluates a simplified biochemical screening strategy to differentiate Glucocorticoid-Remediable Aldosteronism (GRA) from Aldosterone-Producing Adenoma (APA). The approach combines a 1-mg overnight dexamethasone suppression test (ODST) with LC-MS/MS steroid profiling. We aim to establish diagnostic cut-off points for aldosterone and hybrid steroid (18-oxoF, 18-OHF) suppression rates as an efficient screening tool prior to genetic testing.
Detailed description
Background: GRA is a rare form of primary aldosteronism where aldosterone secretion is regulated by ACTH. This study evaluates if a 1-mg ODST can effectively suppress aldosterone and hybrid steroids in GRA patients compared to the autonomous secretion observed in APA.Methods: * Participants: Patients with genetically confirmed GRA or clinically/pathologically confirmed APA are enrolled. * Procedure: Patients undergo a 1-mg ODST (1 mg dexamethasone at midnight). Blood samples are collected at 08:00 AM at baseline and post-suppression. * Analysis: 11 steroids, including ALD, 18-oxoF, and 18-OHF, are measured via LC-MS/MS. * Evaluation: Diagnostic performance is assessed using ROC curves and negative predictive value (NPV) based on a 1% GRA prevalence.Perspective: This initial phase establishes the diagnostic parameters, which will be further validated in a larger cohort to optimize the screening workflow for primary aldosteronism.
Interventions
DIAGNOSTIC_TEST1 mg overnight dexamethasone inhibition test
After the patient fasted overnight, venous blood was collected at 08:00 in the morning for baseline steroid profile analysis (including aldosterone, 18-oxycortisol, 18-hydroxy cortisol, etc., a total of 11 types of steroid hormones). At 24:00 that night, the patient took a single oral dose of 1mg dexamethasone tablets. At 08:00 the next morning, venous blood was collected again under the same collection conditions as the baseline to conduct the baseline steroid profile analysis.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with Primary Aldosteronism (PA) according to clinical biochemical screening standards. GRA Group: Genetically confirmed presence of the $CYP11B1/CYP11B2$ chimeric gene. APA group：The patient was diagnosed with PA and the adrenal imaging showed a typical adrenal adenoma on one side. The AVS or Ga68-Pentixafor PET/CT indicated that the adrenal gland on the adenoma side had a dominant secretion of aldosterone. And any of the following conditions was met: (1) The postoperative pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+). (2) After unilateral adrenal resection, the biochemical results of the patient were completely relieved, meeting the surgical outcome criteria for PA.
Exclusion criteria
* Exclude patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe cardiac and renal insufficiency (eGFR \< 30 mL/min/1.73m²), or those who are unable to cooperate to complete the trial process for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST | Post-1mg ODST (approximately 2 weeks after dexamethasone administration) |
Secondary
| Measure | Time frame |
|---|---|
| Absolute concentration of Plasma Aldosterone (PAC) post-1mg ODST | Post-1mg ODST (approximately 2 weeks after dexamethasone administration) |
| Absolute concentration and percent suppression of 11 steroids (including 18-oxoF and 18-OHF). | Post-1mg ODST (approximately2 weeks after dexamethasone administration) |
Countries
China
Outcome results
None listed