Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

Chongqing Medical University

Status: Completed

Conditions: Primary Aldosteronism

Treatments: Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

Study type: Observational

Funder types: Other

Identifiers

NCT04193137

OSL-study 2019

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Primary Aldosteronism(PA)

Description:

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

Treatment:

Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

non Primary Aldosteronism

Description:

ARR\<10 pg/μIU or ARR\>10 pg/μIU and PAC post FST\<60pg/ml

Treatment:

Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test