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Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion

Q

Qifu Li

Status

Enrolling

Conditions

Autonomous Cortisol Secretion
Adrenal Insufficiency
Primary Aldosteronism

Treatments

Diagnostic Test: complete ACTH stimulation test the day after surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06955286
2025-040-01

Details and patient eligibility

About

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS).

Full description

This study is a prospective, single-center research. Primary aldosteronism patients concurrent with or without autonomous cortisol secretion who underwent adrenalectomy and completed the adrenocorticotropic hormone (ACTH) stimulation test will be included. To evaluate the incidence of adrenal insufficiency after surgery in these patients.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • PA conccurent with or without autonomous cortisol secretion
  • complete adrenalectomy
  • complete ACTH stimulation test on the one day after surgery
  • complete follow-up at 6,12 months after surgery

Exclusion criteria

  • Patients underwent partial adrenalectomy
  • Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history]
  • Suspicion of pheochromocytoma or adrenal carcinoma.
  • Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m2) or Underweight (BMI≤18 kg/m2); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
  • Patients with actively malignant tumor.
  • Long- term use of glucocorticoids.
  • Suspected PBMAH or PPNAD;

Trial design

200 participants in 1 patient group

Patients With Primary Aldosteronism Concurrent With or Without Autonomous Cortisol Secretion
Description:
primary aldosteronism patients concurrent with autonomous cortisol secretion underwent surgical treatment and completed the ACTH stimulation test
Treatment:
Diagnostic Test: complete ACTH stimulation test the day after surgery

Trial contacts and locations

1

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Central trial contact

Li Qifu, PhD

Data sourced from clinicaltrials.gov

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