About this trial
This study is a prospective, multicenter, randomized clinical trial aimed to compare the impact of three AVS diagnostic strategies on the clinical outcomes of patients with primary aldosteronism. The strategies include sequential combined AVS (non-ACTH-stimulated followed by ACTH-stimulated AVS), non- ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. The findings of this study will provide critical evidence for the clinical practice standards of AVS.
Eligibility criteria
Qualifiers
Fully understand the study process, voluntarily agree to participate, and sign informed consent.
Diagnosed with primary aldosteronism. # Age 18-70 years with hypertension, any sex.
Disqualifiers
Patients for whom AVS can be bypassed: Typical BPA (normal serum potassium and plasma aldosterone concentration (PAC) < 110 pg/mL, eligible for direct medical therapy); Typical UPA (PAC ≥ 200 pg/mL, plasma renin concentration (PRC) ≤ 5 μIU/mL, spontaneous hypokalemia, unilateral adrenal adenoma ≥ 1 cm with normal contralateral adrenal on CT or 68Ga-Pentixafor PET-CT indicating unilateral functional tumor, eligible for direct surgery);
Refusal of AVS or surgery, or contraindication to surgery.
Allergy to ACTH or contrast agents.
Combined with autonomous cortisol secretion (1 mg overnight dexamethasone suppression test cortisol ≥ 50 nmol/L).
Trial design
Treatments tested in this trial
- sequential combined AVS
Treatment groups
Sponsors and collaborators
Shumin Yang
Lead sponsor
Chongqing Medical University
Sponsor institution
First Affiliated Hospital of Kunming Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
The People's Hospital of Chuxiong Yi Autonomous Prefecture
Collaborator