Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07691801

Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Aldosterone and Renin Activity in the Diagnosis of Primary Aldosteronism by Captopril Test

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS/MS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Normal Control Group

Inclusion criteria

  • Age 18-70 years old
  • BMI: 18.5-23.9kg/m²
  • 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
  • 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

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 captopril suppression 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

Treatment and study plan

Captopril inhibition test(CCT)

Diagnostic Test

The subjects are required to stop using any drugs that affect the RAAS system in advance. At 08:00 on the test day, they are to remain seated and collect baseline blood samples. Then, they are to take 25mg of captopril orally. After taking the medicine, they are to remain seated and fast for 2 hours, and then collect blood samples again at 10:00. The blood samples collected at these two time points will undergo mass spectrometry analysis to detect plasma aldosterone and renin activity, and 24-hour urine samples will be collected to measure 24-hour urine sodium and 24-hour urine potassium.

Primary outcomes

  1. Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test

    Time frame: Two weeks after completing the captopril inhibition test

  2. Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test

    Time frame: Two weeks after completing the captopril inhibition test

  3. Aldosterone-renin ratio(ARR)by LC-MS/MS before and after captopril inhibition test

    Time frame: Two weeks after completing the captopril inhibition test

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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.