Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShumin Yang

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

456 Participants
are divided into 3 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