Shortening the Oral Sodium Loading Test for Diagnosing Primary Aldosteronism

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

This study is testing if a shorter 2-day sodium loading test can accurately diagnose primary aldosteronism, compared to the traditional 3-day method, for people with this condition.

Quick facts

• Study type: Observational
• Enrollment: 33 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06750172 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the effectiveness of a 2-day oral sodium loading test against the traditional 3-day method for diagnosing primary aldosteronism. It involves 17 healthy controls and 15 patients diagnosed with primary aldosteronism, who will follow a high-sodium diet for 3 days. The study will measure 24-hour urinary aldosterone levels on both the second and third days to determine if the shorter test can reliably replace the longer one. The goal is to simplify the diagnostic process while maintaining accuracy.

Who should consider this trial

Good fit: Ideal candidates include patients aged 20-70 with hypertension and hypokalemia diagnosed with primary aldosteronism.

Not a fit: Patients with other causes of endocrine hypertension or significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could streamline the diagnostic process for primary aldosteronism, making it less burdensome for patients.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in simplifying diagnostic methods for endocrine disorders.

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,

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Tong Anli

Conditions Primary Aldosteronism; diagnose; the oral sodium loading test