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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

ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-70 years old

BMI: 18.5-23.9kg/m²

Gender not restricted

Blood pressure: 100-120/60-80mmHg

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: normal sujects1 intervention
Group B: Patients suspected of having primary aldosteronism1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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