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:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT04461535
Eligibility Criteria:
1.Inclusion criteria: Patients who meet the following criterion can be included in this study.
1. Aged between 18-70, male or female, with legal capacity
2. PA diagnosis confirmed by at least one confirmatory test: positive PA screening (ARR≥ 2.0 ng·dl-1/IU·l-1) and at least one positive PA confirmatory test (PAC-post CCT ≥11 ng/dl, PAC-post SSIT≥8·0 ng/dl, or if confirmatory tests were in grey zone (i.e, PAC 8-11 ng/ml two hours after administration of 50 mg captopril or PAC 60-80 pg/ml after the infusion of 2L normal saline), PAC-post FST≥6·0 ng/dl);
2.Exclusion criteria: Patients with one of the following conditions will be excluded in this study:
1. refusal by the patient to undergo AVS or adrenalectomy;
2. meeting the criteria for bypassing AVS \[i.e. younger than 35 years old, with typical aldosterone-producing adenomas characteristics (plasma aldosterone \>30ng/dl, serum potassium \<3·5mmol/l, CT indicated unilateral 1cm low-density adenoma) ;
3. allergic to ACTH or contrast media;
4. pregnant or lactating women;
5. patients with a history of uncontrolled malignant tumor;
6. complicated with Cushing's syndrome \[including subclinical Cushing: cortisol after 1mg dexamethasone suppression test (DST)\>138 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)\<10pg/ml;
7. diagnosed with familial hyperaldosteronism;
8. with imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
9. patients unsuitable for surgery, such as those with heart failure (New York Heart Association (NYHA) class III or IV), severe anemia (Hemoglobin\<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate\<30ml/min/m2;
10. with alcohol or drug abuse and active mental health disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04461535
Study Brief:
Protocol Section:
NCT04461535