Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination … (NCT07691801) | Clinical Trial Compass
RecruitingNot Applicable
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
China800 participantsStarted 2025-04-28
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
Timeframe: Two weeks after completing the captopril inhibition test
2
Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test
Timeframe: Two weeks after completing the captopril inhibition test
3
Aldosterone-renin ratio(ARR)by LC-MS/MS before and after captopril inhibition test
Timeframe: Two weeks after completing the captopril inhibition test