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Идёт набор NCT07691801

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

— Наблюдательное Primary Aldosteronism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Captopril inhibition test(CCT).
Кому может быть актуально
Состояния в реестре: Primary Aldosteronism. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Вмешательства

  • Диагностический тест 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-ho

Первичные конечные точки

  • Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test [Срок оценки: Two weeks after completing the captopril inhibition test]
  • Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test [Срок оценки: Two weeks after completing the captopril inhibition test]
  • Aldosterone-renin ratio（ARR）by LC-MS/MS before and after captopril inhibition test [Срок оценки: Two weeks after completing the captopril inhibition test]

Критерии участия

Normal Control Group

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Peking Union Medical Colledge Hospital — Пекин

Идентификаторы

NCT: NCT07691801 · pumch-06086-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗