A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 1 mg overnight dexamethasone inhibition test (Diagnostic 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.
干预措施: 1 mg overnight dexamethasone inhibition test (Diagnostic Test)
结局指标
主要结局
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST
时间窗: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)
次要结局
- 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))