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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07691801
Enrollment
800
Registered
2026-07-09
Start date
2025-04-28
Completion date
2026-08-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

diagnose, Captopril Inhibition Test (CCT)

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCaptopril inhibition test(CCT)

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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition testTwo weeks after completing the captopril inhibition test
Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition testTwo weeks after completing the captopril inhibition test
Aldosterone-renin ratio(ARR)by LC-MS/MS before and after captopril inhibition testTwo weeks after completing the captopril inhibition test

Countries

China

Contacts

CONTACTTong Anli
tonganli@hotmail.com+8613460884085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026