A National Multicenter Study of Adrenal Venous Sampling for the Subtype Diagnosis of Primary Aldosteronism in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 48
- 主要终点
- The success rate of bilateral adrenal venous sampling
研究概览
简要总结
This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be aslo analyzed in this study.
详细描述
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. This multicenter registry study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of AVS via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be also analyzed in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 65 with no limits in sex;
- •Patients with confirmed primary aldosteronism;
- •Patients or their legal representatives sign written informed consent approved by the ethics committee；
排除标准
- •Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
- •An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
- •Patients who refuse adrenalectomy;
- •Suspected of having an adrenocortical carcinoma;
- •Allergy to contrast agent;
- •Pregnant, nursing, or planning to become pregnant
结局指标
主要结局
The success rate of bilateral adrenal venous sampling
时间窗: At AVS procedure
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
次要结局
- The success rate of left adrenal venous sampling(At AVS procedure)
- The success rate of right adrenal venous sampling(At AVS procedure)
- Time of the procedure(At AVS procedure)
- The contrast agent dosage(At AVS procedure)
- pathological results（If the patient underwent adrenalectomy）(1 week After AVS procedure)
- the cost of the procedure(At AVS procedure)
- Time of fluoroscopy(At AVS procedure)
- the incidence of complications(1 week after AVS procedure)
- Selection of intraoperative catheter(At AVS procedure)
研究者
Xiongjing Jiang
professor
Chinese Academy of Medical Sciences, Fuwai Hospital