Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

Completed

• Conditions: Primary Aldosteronism
• Interventions: Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test

• Registration Number: NCT04193137
• Lead Sponsor: Chongqing Medical University

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

Study Timeline

• Study Start: 2019-11-30
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-08
• Study First Posted: 2019-12-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Aldosteronism(PA)	Oral sodium loading test,Seated saline infusion test and Captopril challenge test	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
non Primary Aldosteronism	Oral sodium loading test,Seated saline infusion test and Captopril challenge test	ARR\<10 pg/μIU or ARR\>10 pg/μIU and PAC post FST\<60pg/ml

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the optimal cutoff value of urine aldosterone in oral sodium test	3 days	urine aldosterone

Trial Locations

Locations (1)

Qifu Li; 🇨🇳 Chongqing, Chongqing, China