Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

N/ACompletedNCT04193137

Chongqing Medical University200 enrolled

Overview

To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Primary Aldosteronism

Interventions

Oral sodium loading test,Seated saline infusion test and Captopril challenge testDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. hypertensive patients with ARR≥10(pg/ml)(uIU/ml) 2. hypertensive patients with ARR\<10(pg/ml)(uIU/ml) but suspicious of PA clinically Exclusion Criteria: 1. Pregnancy or lactation; 2. Child-bearing women refuse to take effective contraceptive measures; 3. History of malignant tumor; 4. Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months 5. NYHA III (New York Heart Association)and above 6. Hypohepatia 7. Chronic kidney disease with an estimated Glomerular Filtration Rate \<30ml/min/1.73 m² 8. Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound 9. Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study

Locations (1)

Qifu Li

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test

sensitivity, specificity and area under curve (AUC)

Time frame: 9 days

Secondary Outcomes

the optimal cutoff value of urine aldosterone in oral sodium test

urine aldosterone

Time frame: 3 days

Data from ClinicalTrials.gov

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