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NCT Number: NCT07700888

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.

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Key information

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical Colledge Hospital

Beijing, 李泽文, 456350, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

Secondary outcomes

  1. Absolute concentration of Plasma Aldosterone (PAC) post-1mg ODST

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

  2. Absolute concentration and percent suppression of 11 steroids (including 18-oxoF and 18-OHF).

    Time frame: Post-1mg ODST (approximately2 weeks after dexamethasone administration)

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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