Detecting primary aldosteronism in Australian primary care: a prospective study.
Renata Libianto, Grant M Russell, Michael Stowasser...
https://pubmed.ncbi.nlm.nih.gov/35218017Actively Recruiting
Age: 18Years - 70Years
All Genders
ID06955286
Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients With or Without Autonomous Cortisol Secretion
Led by Qifu Li · Updated on 2026-05-01
521
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of adrenal insufficiency after surgery in patients with Primary Aldosteronism (PA), both with and without autonomous cortisol secretion (ACS). The study aims to understand how often this condition occurs, how long it takes for adrenal function to recover after surgery, and to identify clinical features and predictors for patients who may need hormone replacement therapy after the operation. This research is conducted as a prospective, single-center observational study. The study involves patients diagnosed with PA or ACS who have undergone unilateral adrenal surgery. Participants complete an adrenocorticotropic hormone (ACTH) stimulation test the day after surgery, with additional ACTH tests performed 1 or 4 weeks later for those showing signs of adrenal insufficiency. The study includes groups of patients with PA alone, PA concurrent with ACS, and ACS alone, all undergoing surgical treatment and the ACTH stimulation test. Participants will be monitored through scheduled ACTH stimulation tests shortly after surgery and during follow-up visits at 1 and 4 weeks, as well as 3 and 6 months post-surgery. Researchers will assess the incidence of adrenal insufficiency immediately after surgery, track recovery times over the following months, and evaluate clinical characteristics linked to the need for hormone replacement therapy. The study's total duration includes these follow-up periods to gather detailed data on patient outcomes and recovery.
CONDITIONS
Brief Title
Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion
- Completion of unilateral adrenal surgery
- Voluntary participation with informed consent
- Age between 18 and 70 years
- Both male and female participants are eligible
You will not qualify if you...
- Typical clinical manifestations of Cushing's syndrome
- Suspected bilateral cortisol over-secretion such as PBMAH or PPNAD
- Severe surgical complications or unstable postoperative condition unrelated to adrenal insufficiency
- History of allergy to ACTH
- Requirement for long-term hormone therapy for other diseases like autoimmune disorders
- Severe liver dysfunction (ALT ≥ 3 times upper limit of normal)
- Severe kidney dysfunction (dialysis or estimated glomerular filtration rate < 30 ml/min/m2)
- History of contralateral adrenal surgery
- Poor compliance preventing completion of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo adrenalectomy surgery and complete the ACTH stimulation test the day after surgery to assess adrenal function.
1 visit (in-person)
Post-operative Follow-up
Duration - 1 to 4 weeks
Participants with adrenal insufficiency complete additional ACTH stimulation tests at 1 or 4 weeks after surgery to evaluate recovery and adrenal function.
1 to 2 visits depending on adrenal insufficiency status (in-person)
Long-term Monitoring
Duration - Up to 6 months
Participants are monitored for clinical characteristics and recovery related to adrenal insufficiency, including hormone replacement therapy needs, up to 3 or 6 months after surgery.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Loading map...
Research Team
L
Li Qifu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Primary Aldosteronism in Patients in China With Recently Detected Hypertension.
Zhixin Xu, Jun Yang, Jinbo Hu...
https://pubmed.ncbi.nlm.nih.gov/32327102Cardiovascular complications of patients with aldosteronism associated with autonomous cortisol secretion.
Yasuyo Nakajima, Masanobu Yamada, Ryo Taguchi...
https://pubmed.ncbi.nlm.nih.gov/21593113Japan Endocrine Society clinical practice guideline for the diagnosis and management of primary aldosteronism 2021.
Mitsuhide Naruse, Takuyuki Katabami, Hirotaka Shibata...
https://pubmed.ncbi.nlm.nih.gov/35418526Autonomous cortisol secretion in patients with primary aldosteronism: prevalence and implications on cardiometabolic profile and on surgical outcomes.
Marta Araujo-Castro, Miguel Paja Fano, Begoña Pla Peris...
https://pubmed.ncbi.nlm.nih.gov/37410097Primary aldosteronism associated with subclinical Cushing syndrome.
K Fujimoto, S Honjo, H Tatsuoka...
https://pubmed.ncbi.nlm.nih.gov/23385627Primary aldosteronism with mild autonomous cortisol secretion increases renal complication risk.
Takuyuki Katabami, Ren Matsuba, Hiroki Kobayashi...
https://pubmed.ncbi.nlm.nih.gov/35380982Cortisol-producing adenoma-related somatic mutations in unilateral primary aldosteronism with concurrent autonomous cortisol secretion: their prevalence and clinical characteristics.
Wan-Chen Wu, Kang-Yung Peng, Jin-Ying Lu...
https://pubmed.ncbi.nlm.nih.gov/35900323[Clinical characteristics and prognosis of primary aldosteronism associated with subclinical Cushing syndrome].
Y Y Liao, Y Song, J B Hu...
https://pubmed.ncbi.nlm.nih.gov/38561283Selective Glucocorticoid Replacement Following Unilateral Adrenalectomy for Hypercortisolism and Primary Aldosteronism.
Olivia M DeLozier, Sophie Y Dream, James W Findling...
https://pubmed.ncbi.nlm.nih.gov/34558612