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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chongqing, Chongqing, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported