Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism
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ClinicalTrials.gov Identifier: NCT04193137 |
Recruitment Status :
Completed
First Posted : December 10, 2019
Last Update Posted : August 4, 2021
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Condition or disease | Intervention/treatment |
---|---|
Primary Aldosteronism | Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test |
Study Type : | Observational |
Actual Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism |
Actual Study Start Date : | November 30, 2019 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Primary Aldosteronism(PA)
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
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Diagnostic Test: Oral 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. |
non Primary Aldosteronism
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
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. |
- Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test [ Time Frame: 9 days ]sensitivity, specificity and area under curve (AUC)
- the optimal cutoff value of urine aldosterone in oral sodium test [ Time Frame: 3 days ]urine aldosterone
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193137
China, Chongqing | |
Qifu Li | |
Chongqing, Chongqing, China, 400016 |
Study Chair: | Qifu Li, PhD | the Chongqing Primary Aldosteronism Study (CONPASS) Group |
Responsible Party: | Qifu Li, Primary Investigator, Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT04193137 |
Other Study ID Numbers: |
OSL-study 2019 |
First Posted: | December 10, 2019 Key Record Dates |
Last Update Posted: | August 4, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
primary aldosteronism, oral sodium loading test captopril challenge test, Saline infusion test |
Hyperaldosteronism Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Captopril |
Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |