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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| non Primary Aldosteronism | ARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral sodium loading test,Seated saline infusion test and Captopril challenge test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test | sensitivity, specificity and area under curve (AUC) | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| the optimal cutoff value of urine aldosterone in oral sodium test | urine aldosterone | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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hypertensive patients being suspicious of PA in a single tertiary hospital center
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| Name | Affiliation | Role |
|---|---|---|
| Qifu Li, PhD | the Chongqing Primary Aldosteronism Study (CONPASS) Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qifu Li | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26934393 | Result | Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. | |
| 30255616 | Result |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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Serum, plasma and complete blood cell. 24-h urine, etc
|
| Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25. |
| 30721529 | Result | Wu S, Yang J, Hu J, Song Y, He W, Yang S, Luo R, Li Q. Confirmatory tests for the diagnosis of primary aldosteronism: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2019 May;90(5):641-648. doi: 10.1111/cen.13943. Epub 2019 Feb 26. |
| 16670162 | Result | Mulatero P, Milan A, Fallo F, Regolisti G, Pizzolo F, Fardella C, Mosso L, Marafetti L, Veglio F, Maccario M. Comparison of confirmatory tests for the diagnosis of primary aldosteronism. J Clin Endocrinol Metab. 2006 Jul;91(7):2618-23. doi: 10.1210/jc.2006-0078. Epub 2006 May 2. |
| 21828936 | Result | Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9. |
| 27607462 | Result | Mulatero P, Monticone S, Burrello J, Veglio F, Williams TA, Funder J. Guidelines for primary aldosteronism: uptake by primary care physicians in Europe. J Hypertens. 2016 Nov;34(11):2253-7. doi: 10.1097/HJH.0000000000001088. |