Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04193137

Enrollment

200

Registered

2019-12-10

Start date

2019-11-30

Completion date

2021-06-30

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism,, oral sodium loading test, captopril challenge test,, Saline infusion test

Brief summary

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

Detailed 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

Interventions

DIAGNOSTIC_TESTOral sodium loading test,Seated saline infusion test and Captopril challenge 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
the optimal cutoff value of urine aldosterone in oral sodium test	3 days	urine aldosterone

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026