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To compare the consistency of 24-hour urinary aldosterone in the diagnosis of primary aldosteronism by oral sodium loading test between the second day method and the third day method
This is an exploratory and prospective study of 17 healthy controls and 15 patients with primary aldosteronism, in which each participant will receive a high-sodium diet for 3 days to conduct a confirmatory test for primary aldosteronism. The consistency between the 2-day and 3-day oral sodium loading test for the diagnosis of primary aldosteronism is compared by measuring the 24-hour urinary aldosterone levels of the participants on the second and third days of the high-sodium diet. The study aims to explore whether the 24-hour urinary aldosterone level on the second day can replace the 24-hour urinary aldosterone level on the third day for the diagnosis of primary aldosteronism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary aldosteronism(PA) | Inclusion criteria: Patients with hypertension and hypokalemia who have been diagnosed with primary aldosteronism following the latest version international guidelines for primary aldosteronism. Exclusion criteria:
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| healthy control | Inclusion criteria:
Exclusion criteria: History of hypokalemia. History of liver and kidney dysfunction, malignant tumors, metabolic disorders, cardiovascular diseases, and psychiatric disorders, etc. Menstrual irregularities and taking contraceptive pills.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The oral sodium loading test | Diagnostic Test | The subjects underwent an oral high-salt diet test with an additional 10g of salt per day for 3 consecutive days, and 24-hour urine measurements of aldosterone, sodium, potassium and creatinine were obtained on days 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of 2-day and 3-day 24h urinary aldosterone in the oral sodium load test | To explore whether there was statistical difference in the 24h urinary aldosterone on the 2nd day and the 3rd day detected by LC-MS (Liquid chromatography-tandem mass spectrometry) in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism | 4 day |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of 2-day and 3-day PAC(Plasma aldosterone concentration) in the oral sodium load test | To explore whether there was statistical difference in plasma aldosterone concentration on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism. | 4 day |
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PA patients:
Inclusion criteria:
Exclusion criteria:
Inclusion criteria:
Exclusion criteria:
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Healthy Volunteers and patients with primary aldosteronism in a single tertiary hospital center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tong Anli | Contact | +8613460884085 | tonganli@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36045149 | Result | Turcu AF, Yang J, Vaidya A. Primary aldosteronism - a multidimensional syndrome. Nat Rev Endocrinol. 2022 Nov;18(11):665-682. doi: 10.1038/s41574-022-00730-2. Epub 2022 Aug 31. | |
| 24711520 | Result | Funder JW. Sensitivity to aldosterone: plasma levels are not the full story. Hypertension. 2014 Jun;63(6):1168-70. doi: 10.1161/HYPERTENSIONAHA.114.03127. Epub 2014 Apr 7. No abstract available. |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
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Serum, plasma and complete blood cell. 24-hour urine, etc
| Consistency of the plasma renin activity on the second day and the third day in oral sodium load test | To explore whether there was statistical difference in the plasma renin activity on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism | 4 day |
| consistency of the the aldosterone-to-renin ratio(ARR) on the second day and the third day in oral sodium load test | To explore whether there was statistical difference in the aldosterone-to-renin ratio on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism | 4 day |
| 30703073 | Result | Kline GA, Darras P, Leung AA, So B, Chin A, Holmes DT. Surprisingly low aldosterone levels in peripheral veins following intravenous sedation during adrenal vein sampling: implications for the concept of nonsuppressibility in primary aldosteronism. J Hypertens. 2019 Mar;37(3):596-602. doi: 10.1097/HJH.0000000000001905. |
| 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. |
| 17161262 | Result | Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13. |
| 28385310 | Result | Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052. |
| D013568 | Pathological Conditions, Signs and Symptoms |