Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Area under the receiver operating characteristic curve (AUC) for Salt loading test
研究概览
简要总结
To optimize the confirmatory tests for primary aldosteronism.
详细描述
In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With hypertension;
- •With adrenal diseases
排除标准
- •Pregnant or during lactation period;
- •Under 18 yr;
- •BMI ≤ 19 or ≥ 35
- •With Cancer medical history
- •Been through cardiovascular diseases in the past 3 months;
- •Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.
结局指标
主要结局
Area under the receiver operating characteristic curve (AUC) for Salt loading test
时间窗: 1 week
Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated.
AUC for fludrocortisone suppression test
时间窗: 1 week
Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
AUC for captopril challenge test
时间窗: 1 week
Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
次要结局
- Incidence of cardiovascular diseases in Primary Aldosteronism(3 years)
研究者
Qifu Li
M.D., PhD
Chongqing Medical University