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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT06100367
Eligibility Criteria:
Inclusion Criteria:
* For patients with primary aldosteronism (PA\_CURE 2 / PA\_MTO EH):
1. Confirmed diagnosis of primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone \>140pmol/L); or hypokalemia with undetectable renin levels and aldosterone \>550pmol/L; or likely primary aldosteronism / low-renin hypertension (inappropriate aldosterone levels and suppressed renin levels)
2. Keen for surgical treatment if shown to have unilateral adrenal disease.
* For patients with suspected adrenal tumors (PA\_MTO AT)
1. All patients with suspected adrenal tumors based on imaging and clinical suspicion.
Exclusion Criteria:
* Inability to provide written informed consent.
* Chronic renal failure of Stage 3b or greater severity, estimated glomerular filtration rate (eGFR) \< 45ml/min/1.73m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. (only applicable for PA\_CURE 2 / PA\_MTO EH)
* Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure (only applicable for PA\_CURE 2 / PA\_MTO EH)
* Contraindications to isotope scanning (e.g. Female patients who are pregnant (self-declared or via positive pregnancy test), intending to become pregnant (within 3 months of scan) or breastfeeding) or CT Scan, which includes but not limited to waist circumference \>140cm, morbid obesity or claustrophobia (limiting entry in CT scanner)
* Contraindication to ingestion of corticosteroids (e.g. poorly controlled diabetes, HbA1C \>13%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT06100367
Study Brief:
Protocol Section:
NCT06100367