Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

Study Overview
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Brief Summary
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To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

Detailed Description
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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

Official Title
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Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hypertensive patients with ARR≥10(pg/ml)(uIU/ml) hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Aldosteronism(PA)<br>plasma aldosterone /renin ratio (ARR)>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC>200 pg/ml，plasma renin concentration(PRC)<2.5μIU/ml，with hypokalemia | Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test<br>* Oral sodium loading test : Patients received 6g oral sodium every day for 3 days. Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.<br>|
| non Primary Aldosteronism<br>ARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml | Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test<br>* Oral sodium loading test : Patients received 6g oral sodium every day for 3 days. Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test | sensitivity, specificity and area under curve (AUC) | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the optimal cutoff value of urine aldosterone in oral sodium test | urine aldosterone | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary aldosteronism,, oral sodium loading test, captopril challenge test,, Saline infusion test