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

NCT07700888 | Completed

• 1 other identifier: pumch-06086-09
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma

Keywords

1 mg overnight dexamethasone inhibition test; screening

Outcome Measures

Primary Outcomes (1)

• Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST

  Post-1mg ODST (approximately 2 weeks after dexamethasone administration)

Secondary Outcomes (2)

• 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)

Study Arms (2)

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

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

Interventions

1 mg overnight dexamethasone inhibition test DIAGNOSTIC_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.

Aldosterone-producing adenoma; Familial hyperaldosteronism type 1

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical Colledge Hospital

Beijing, 李泽文, 456350, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)