Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06750172

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

Location status: Recruiting

Location contact

Tong Anli

CONTACT

[email protected]

13460884085

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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 outcomes

  1. Consistency of 2-day and 3-day 24h urinary aldosterone in the oral sodium load test

    Time frame: 4 day

    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

Secondary outcomes

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

    Time frame: 4 day

    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.

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

    Time frame: 4 day

    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

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

    Time frame: 4 day

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.