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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

7. juli 2026 opdateret af: Peking Union Medical College Hospital
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 456350

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients suspected of having primary aldosteronism
Diagnostisk test: Captopril 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.
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.
Diagnostisk test: Captopril 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
Tidsramme: Two weeks after completing the 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
Tidsramme: Two weeks after completing the 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
Tidsramme: Two weeks after completing the captopril inhibition test
Two weeks after completing the captopril inhibition test

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. april 2025

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • pumch-06086-11

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Primær aldosteronisme

Kliniske forsøg med Captopril inhibition test(CCT)

Søg i lignende forsøg

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