Clinical trial Recruiting at 1 site Observational Ages 18 to 70

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

Official title: 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

Run by Peking Union Medical College Hospital · NCT07691801 · Data updated 2026-11-12

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

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment800 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedApril 28, 2025
Main results expectedAugust 1, 2026
Study endsAugust 1, 2026
Registry record updatedJuly 9, 2026
Trial IDNCT07691801 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–70 without prior hypertension or with suspected primary aldosteronism, including those willing to undergo spironolactone treatment for PA evaluation.

Probably not a fit

Individuals without primary aldosteronism or whose condition is not detectable by this testing approach may not benefit.

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 compares aldosterone measurements by LC-MS/MS to conventional methods during the captopril inhibition test to establish a more precise diagnostic cutoff for primary aldosteronism. It will include healthy volunteers and patients suspected of PA to determine an improved threshold. The goal is to improve diagnostic accuracy and help clinicians identify and treat PA earlier. The study uses a standardized captopril test protocol and analyzes aldosterone and renin activity to refine the diagnostic criteria.

Why it matters

Potential benefit: If successful, clinicians could diagnose primary aldosteronism more accurately using a LC-MS/MS-based cutoff, enabling earlier and more targeted treatment.

How similar studies have gone: Previous methods using LC-MS/MS for aldosterone measurement have shown improved accuracy over radioimmunoassay, but the specific cutoff via CCT with LC-MS/MS is being refined in this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.