Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method

NCT06750172 | Recruiting

• 1 other identifier: pumch-06086-08
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Aldosteronism

Keywords

diagnose; the oral sodium loading test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Consistency of 2-day and 3-day PAC(Plasma aldosterone concentration) in the oral sodium load test

  4 day

• Consistency of the plasma renin activity on the second day and the third day in oral sodium load test

  4 day

• consistency of the the aldosterone-to-renin ratio(ARR) on the second day and the third day in oral sodium load test

  4 day

Study Arms (2)

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: * 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 * Special drugs such as glucocorticoids, immunosuppressants, and oral contraceptives should * Diabetes mellitus with HbA1c\>7.0% or with insulin or SGLT2 inhibitors were also excluded.

Diagnostic Test: The oral sodium loading test

healthy control

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,

Diagnostic Test: The oral sodium loading test

Interventions

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

Primary aldosteronism(PA); healthy control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers and patients with primary aldosteronism in a single tertiary hospital center

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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.
• 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,

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 36045149 BACKGROUND

• 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.

  PMID: 24711520 BACKGROUND

• 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.

  PMID: 30703073 BACKGROUND

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 17161262 BACKGROUND

• 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.

  PMID: 28385310 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and complete blood cell. 24-hour urine, etc

MeSH Terms

Conditions

Hyperaldosteronism; Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tong Anli

CONTACT

+8613460884085; tonganli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 27, 2024
• Study Start: December 15, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)