Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT06635993
Eligibility Criteria:
Inclusion Criteria:
1. Getting the written informed consent
2. The clear diagnosis of primary aldosteronism；
3. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l；
4. Patients who are willing to undergo surgery；
5. Adrenal CT or MRI scan of the adrenal glands with nodule (≥1cm).
Exclusion Criteria:
1. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \>300pg/ml\]；
2. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\]；
3. Suspicion of pheochromocytoma or adrenal carcinoma；
4. Patients with actively malignant tumor；
5. Patients who have adrenalectomy history；
6. Long-term use of glucocorticoids；
7. Patients who are allergic to contrast media and cannot tolerate AVS；
8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders；
9. 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); Untreated aneurysm; Other comorbidity potentially interfering with treatment；
10. Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06635993
Study Brief:
Protocol Section:
NCT06635993