A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism:… (NCT07700888) | Clinical Trial Compass
CompletedNot Applicable
A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile
China50 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
12 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST
Timeframe: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)