Precise urinary aldosterone threshold for diagnosing primary aldosteronism using LC-MS/MS during an oral sodium loading test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will establish a new 24-hour urinary aldosterone threshold measured by LC-MS/MS during the oral sodium loading test to diagnose primary aldosteronism. It will combine biochemical results from healthy volunteers and patients suspected of having PA to determine an optimal cut-off. The aim is to improve diagnostic accuracy and enable earlier, more precise treatment of a potentially curable cause of hypertension. Participants will include healthy adults and outpatients with suspected PA, with data collection focusing on urinary aldosterone and related clinical information. The study is conducted at Peking Union Medical College Hospital without a specified intervention beyond the oral sodium loading test.

Why it matters

Who can join: the full rules

Inclusion criteria for the normal control group: Age 18-70 years old, BMI: 18.5-23.9kg/m ²，gender not restricted. blood pressure: 100-120/60-80mmHg. no history of hypertension. No abnormal nodules found in adrenal CT. Previous blood potassium and electrocardiogram were all within normal ranges., No history of liver or kidney dysfunction, malignant tumors, metabolic diseases or cardiovascular diseases, and no medication used.

Exclusion criteria: Those with a family history of hypertension or with clinical manifestations of secondary hypertension. Those who have been taking drugs that may affect the RAAS system for a long time (such as contraceptives, steroids, etc.). Those with cardiac dysfunction or severe arrhythmia and unable to tolerate the test.

Patients with suspected primary aldosteronism in the outpatient setting. Inclusion criteria: Patients with suspected primary aldosteronism in the outpatient setting. Willing to undergo 4-week spironolactone treatment and cooperate with follow-up.

Exclusion criteria: Patients who did not complete the oral sodium loading test. Patients with Cushing's syndrome or other endocrine tumors. Patients allergic to spironolactone or with contraindications for its use (such as severe hyperkalemia, eGFR \< 30).History of liver or kidney dysfunction, coexisting severe cardiovascular or cerebrovascular diseases, history of malignant tumors, other types of endocrine hypertension (hyperthyroidism, pheochromocytoma, Cushing's syndrome, etc.), renal artery stenosis, hypokalemia caused by other factors (renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.), diabetes with HbA1c \> 7.0% or currently using or having used insulin or SGLT2 inhibitor drugs, taking special medications such as glucocorticoids, immunosuppressants, oral contraceptives, etc.

Where it's running

• Peking Union Medical Colledge Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Tong Anli
• Email: tonganli@hotmail.com
• Phone: +8613460884085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Kidney stiffness measured by ultrasound in hypertension and healthy volunteers

  This study tests whether kidney stiffness measured by a non-invasive ultrasound method differs between people with high blood pressure and healthy individuals.

  Recruiting Azienda Ospedaliera di Padova · Padova, PD · NCT07914075

• Inclisiran vs. Statin for Primary Aldosteronism

  This trial tests whether inclisiran plus amlodipine works differently from a statin-based approach in people with primary aldosteronism and high blood pressure.

  Recruiting Third Military Medical University · Chongqing, Chongqing Municipality · NCT07884955

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Metomidate PET-CT vs Usual Care for Primary Aldosteronism

  This study tests whether [11C] metomidate PET-CT can help orient treatment for people with primary aldosteronism compared with the usual adrenal venous sampling approach.

  Recruiting Chinese University of Hong Kong · Shatin · NCT07814105

• Captopril Test with LC-MS/MS for Aldosterone and Renin in Primary Aldosteronism

  This study tests whether measuring aldosterone with LC-MS/MS during a captopril test can better diagnose primary aldosteronism.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07691801

• Finerenone vs. Spironolactone for Primary Aldosteronism

  This trial tests whether finerenone works as well as spironolactone to lower blood pressure and improve related health measures in adults with primary aldosteronism.

  Recruiting Bangladesh Medical University · Dhaka · NCT07688928

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.