- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07635134
Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Tong Anli
- Telefonnummer: +8613460884085
- E-mail: tonganli@hotmail.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100000
- Rekruttering
- Peking Union Medical Colledge Hospital
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Kontakt:
- Li Zewen
- E-mail: b2023001041@pumc.edu.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria for the normal control group: Age 18-70 years old, BMI: 18.5-23.9kg/m ²,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, and 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 in the outpatient setting. 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 oral sodium loading 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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normal sujects
Healthy volunteers with normal blood pressure and blood potassium levels and no adrenal nodules.
These volunteers were used to determine the normal physiological range (lower limit value) of aldosterone inhibition after the test.
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These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day.
On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.
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Patients suspected of having primary aldosteronism
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These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day.
On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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24-hour urinary aldosterone levels after a 3-day high-sodium diet
Tidsramme: Two weeks after completing the oral sodium loading test
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Two weeks after completing the oral sodium loading test
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- pumch-06086-10
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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