Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
研究概览
简要总结
To compare the diagnostic value of three confirmatory tests for primary aldosteronism.
详细描述
This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
- •hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically
排除标准
- •Pregnancy or lactation;
- •Child-bearing women refuse to take effective contraceptive measures;
- •History of malignant tumor;
- •Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
- •NYHA III (New York Heart Association)and above
- •Hypohepatia
- •Chronic kidney disease with an estimated Glomerular Filtration Rate <30ml/min/1.73 m²
- •Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
- •Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study
结局指标
主要结局
Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
时间窗: 9 days
sensitivity, specificity and area under curve (AUC)
次要结局
- the optimal cutoff value of urine aldosterone in oral sodium test(3 days)
研究者
Qifu Li
Primary Investigator
Chongqing Medical University