NCT07298954

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

Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism: A Multicenter, Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Shumin Yang · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, multicenter, randomized controlled clinical trial. This study will be led by the First Affiliated Hospital of Chongqing Medical University, with Chuxiong Yi Autonomous Prefecture People's Hospital, the First Affiliated Hospital of Kunming Medical University, and the First Affiliated Hospital of Nanchang Medical University serving as collaborating centers. According to the inclusion and exclusion criteria, eligible patients with confirmed primary aldosteronism (PA) will be enrolled and randomly assigned in a 1:1:1 ratio to one of the following groups: sequential combined AVS, non-ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. These stratifications will guide clinical treatment decisions, either surgical therapy or medical therapy, and patients will be followed to evaluate their clinical outcomes. The primary outcome is the treatment response rate at 6-month follow-up, which will be compared among the three groups.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	sequential combined AVS	non-ACTH-stimulated followed by ACTH-stimulated AVS

Timeline

• Start date: 2025-12-25
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-23
• Last updated: 2025-12-24

Locations

1 site across 1 country: China