A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile

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.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Intervention / Treatment: Diagnostic test: 1 mg overnight dexamethasone inhibition test

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • 李泽文
    • Beijing, 李泽文, China, 456350
      • Peking Union Medical Colledge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 31 patients diagnosed with Primary Aldosteronism (PA), including 8 cases of genetically confirmed Glucocorticoid-Remediable Aldosteronism (GRA) and 23 cases of Aldosterone-Producing Adenoma (APA).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aldosterone-producing adenoma; APA group (control group): Patients diagnosed with PA and whose adrenal imaging indicated the presence of a typical adrenal adenoma on one side, with AVS or Ga68-Pentixafor PET/CT suggesting that the adenoma side had a dominant secretion of aldosterone, and meeting any of the following criteria: (1) Post-surgical pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+); (2) Patients who underwent unilateral adrenal resection achieved complete biochemical remission and met the surgical outcome criteria for PA. Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal and cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who could not cooperate to complete the trial process for any reason were excluded.	Diagnostic test: 1 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.
Familial hyperaldosteronism type 1; GRA group (case group): Patients who met the biochemical diagnostic criteria for primary aldosteronism, had a clear history of early-onset hypertension or hypertension in their families, and whose CYP11B1/CYP11B2 chimeric gene was confirmed by genetic testing. Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal or cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who cannot cooperate to complete the trial process for various reasons are excluded.	Diagnostic test: 1 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST	Post-1mg ODST (approximately 2 weeks after dexamethasone administration)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: screening; 1 mg overnight dexamethasone inhibition test
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism
• Other Study ID Numbers: pumch-06086-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No