Clinical trial NCT06750172: Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method
Official title: Consistency of 24-hour Urinary Aldosterone on on the Second Day and the Third Day in Diagnosis of Primary Aldosteronism Measured in the Oral Sodium Loading Test by Liquid Chromatography-tandem Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Keywords: diagnose
the oral sodium loading test
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers and patients with primary aldosteronism in a single tertiary hospital center

Brief summary: 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

Detailed description: 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.

Eligibility criteria: PA patients:

Inclusion criteria:

* Patients with hypertension and hypokalemia who have been diagnosed with primary aldosteronism following the latest version international guidelines for primary aldosteronism.
* Age: 20-70 years old, male and female;
* BMI: 18.5-23.9 kg/m2;

Exclusion criteria:

* Other causes of endocrine hypertension including pheochromocytoma, Cushing syndrome, etc.
* Renal artery stenosis and low potassium due to other factors, such as renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.
* History of hyperthyroidism, hepatic and renal insufficiency, malignant tumors, metabolic diseases, cardiovascular diseases, and mental diseases,menstrual disorders Healthy volunteers

Inclusion criteria:

* Age: 20-70 years old, male and female;
* BMI: 18.5-23.9 kg/m2;
* Blood pressure: 90-120/60-80 mmHg on three consecutive office blood pressure readings;
* Female must have regular menstrual cycle (blood and urine samples should be taken during the non-menstrual period);
* Regular dietary habits;
* No medications taken within the past 1 month.

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.
* History of hypertension
* Have taken any drugs including anti-inflammatory drugs, potassium diuretics, or special health products in the 4 weeks prior to the examination,

Primary outcomes:
measure: Consistency of 2-day and 3-day 24h urinary aldosterone in the oral sodium load test
timeFrame: 4 day
Secondary outcomes:
measure: Consistency of 2-day and 3-day PAC(Plasma aldosterone concentration) in the oral sodium load test
timeFrame: 4 day
measure: Consistency of the plasma renin activity on the second day and the third day in oral sodium load test
timeFrame: 4 day
measure: consistency of the the aldosterone-to-renin ratio(ARR) on the second day and the third day in oral sodium load test
timeFrame: 4 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.