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临床试验/NCT05826080
NCT05826080招募中不适用

The Cross-sectional Study and Longitudinal Study of the the Value of Adrenocorticotrophic Hormonestimulation in Adrenal Vein Sampling

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
59
试验地点
1
主要终点
Cortisol metabolism

研究概览

简要总结

The purpose of our research is to evaluate the value of ACTH stimulation in AVS especially in lateralization is still controversial.

详细描述

Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. A recent published study revealed that the prevalence of PA in patients with newly diagnosed hypertension in China was at least 4%. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients.

Adrenal venous sampling (AVS) is key for reliable subtype identification recommended by different guidelines and consensus statements. However, AVS is a complex, technically challenging and expensive procedure, requiring proficient and dedicated interventional radiologists. More importantly, the standardised procedure and method of AVS have not been unified10. Adrenocorticotropic hormone (ACTH) infusion is employed by many centers to maximize the gradient in cortisol from the adrenal vein to the inferior vena cava, and to maximize aldosterone secretion from an aldosterone-producing adenomas (APA) and thus avoid the risk of sampling during a relatively quiescent phase of aldosterone secretion. There is no debate that ACTH stimulation increases the selectivity index (SI) and, therefore, greatly increases the likelihood of successful AVS. However, the effect of ACTH stimulation on the lateralization index (LI) is controversial, with several studies reporting a reduction in the proportion of lateralized AVS results and, therefore, of surgically treatable patients. Hitherto, most of the studies on the value of using ACTH stimulation in AVS are retrospective studies with a small sample size, or multi-center studies with ununified methods of ACTH stimulation and evaluation standards of results. Therefore, there are obvious heterogeneity in the results and the value of evidence is limited.

In this prospective study, we analyzed the SI and LI in simultaneous bilateral AVS at baseline and after ACTH stimulation in our center, and further estimated the prognosis of patients underwent adrenalectomy with different cut-off points of LI after ACTH stimulation. Present study will provide novel evidence for the value of ACTH stimulation in AVS and improve AVS procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as primary aldosteronism.
  • AVS was performed and conservative treatment or adrenalectomy was performed according to the results.
  • Regular follow-up was performed.

排除标准

  • Adrenal function evaluation suggests that it is complicated with hypercortisolism, subclinical hypercortisolism and pheochromocytoma.
  • Familial aldosteronism.
  • .Adrenal mass is considered to be malignant, or pathology suggests adrenocortical carcinoma.
  • .Complicated with severe infection, respiratory and circulatory failure, advanced tumor, severe. hepatic and renal insufficiency, neurological, psychiatric and immune deficiency diseases.
  • .Drugs: discontinuation of β-receptor inhibitors, angiotensin converting enzyme inhibitors, angiotensin Ⅱ receptor blockers, thiazide diuretics < 2 weeks, aldosterone receptor antagonists < 4 weeks.
  • .Pregnant and lactating women.

结局指标

主要结局

Cortisol metabolism

时间窗: 1 day

24-hours urine free cortisol

Physical assessments

时间窗: 1 day

BMI(body mess index) in kg/m\^2

Participants' personal information

时间窗: 1 day

Self-reported information (the cause of discovering adrenal adenoma)

Screening test of primary aldosteronism(Supine standing test)

时间窗: 1 day

plasma renin concentration in the supine position and standing position

Confirmatory test of primary aldosteronism(Captopril test)

时间窗: 1 day

plasma renin concentration at 8:00 am and 10:00 am

circadian cortisol rhythm

时间窗: 1 day

Plasma cortisol concentration at 8:00am、16:00pm and 0:00am

1 mg (overnight) dexamethasone suppression test

时间窗: 1 day

Plasma cortisol concentration at 8:00am

24-hour urine electrolytes

时间窗: 1 day

24-hour urine potassium

Other indicators of adrenal function

时间窗: 1 day

24h urinary,plasma catecholamines and their metabolites

Imaging of adrenal adenoma

时间窗: 1 day

unenhanced and contrast-enhanced CT of adrenal

次要结局

未报告次要终点

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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