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Search / Trial NCT06955286

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

Launched by QIFU LI · Apr 25, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Primary Aldosteronism Autonomous Cortisol Secretion Adrenal Insufficiency Acth Stimulation Test

ClinConnect Summary

This clinical trial is studying how often patients with primary aldosteronism (a condition where the adrenal glands produce too much of a hormone called aldosterone) experience adrenal insufficiency after surgery. Adrenal insufficiency means the adrenal glands do not produce enough hormones, which can lead to various health issues. The trial is looking at patients who have primary aldosteronism, with or without another condition called autonomous cortisol secretion, and aims to find out how surgery affects their hormone levels afterward.

To participate in this trial, patients need to meet certain criteria. They should have primary aldosteronism and be scheduled for a complete adrenalectomy, which is the removal of one or both adrenal glands. Participants will undergo a specific test one day after surgery to check their hormone levels and will have follow-ups at 6 and 12 months later. However, individuals with certain health problems or those who have had partial adrenal surgery, among other exclusions, will not be eligible. It's important for potential participants to understand these requirements and the commitment involved in the follow-up visits.

Gender

ALL

Eligibility criteria

  • 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;

About Qifu Li

Qifu Li is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial designs and rigorous scientific methodologies. With a strong focus on collaboration, Qifu Li partners with leading healthcare institutions and researchers to facilitate the development of new therapies and interventions across various therapeutic areas. The organization prioritizes ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and respect for participant safety. Through its expertise and strategic vision, Qifu Li aims to contribute significantly to the advancement of healthcare and the discovery of transformative treatment options.

Locations

Chongqing, Chongqing, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported