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

NCT07691801 | Recruiting DMC

• 1 other identifier: pumch-06086-11
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism

Keywords

diagnose; Captopril Inhibition Test (CCT)

Outcome Measures

Primary Outcomes (3)

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

  Two weeks after completing the captopril inhibition test

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

  Two weeks after completing the captopril inhibition test

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

  Two weeks after completing the captopril inhibition test

Study Arms (2)

normal sujects

Healthy volunteers with normal blood pressure, normal blood potassium levels, and no adrenal nodules. These individuals were used to establish the normal physiological range (lower limit) of aldosterone suppression after the test.

Diagnostic Test: Captopril inhibition test(CCT)

Patients suspected of having primary aldosteronism

Patients suspected of having primary aldosteronism

Diagnostic Test: Captopril inhibition test(CCT)

Interventions

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.

Patients suspected of having primary aldosteronism; normal sujects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1）Healthy Controls to establish physiological suppression limits.2) Patients with suspected PA undergo captopril inhibition test to determine the cut-off point.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical Colledge Hospital

Beijing, Beijing Municipality, 456350, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tong Anli

CONTACT

+8613460884085; tonganli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 9, 2026
• Study Start: April 28, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)