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

Shumin Yang

Status: Enrolling

Conditions: Primary Aldosteronism

Treatments: Diagnostic Test: sequential combined AVS

Study type: Interventional

Funder types: Other

Identifiers

NCT07298954

SCOPE PA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• Early-onset hypertension (<20 years) with hypokalemia and family history, suggestive of familial hyperaldosteronism or Liddle syndrome.
• Imaging cannot exclude pheochromocytoma or adrenocortical carcinoma (nodule ≥ 4 cm, CT ≥ 20 HU, or MRI suggestive).
• Active malignancy.
• Previous adrenal surgery.
• Chronic glucocorticoid use that cannot be discontinued.
• Adrenal insufficiency requiring hormone replacement.
• Pregnancy or breastfeeding; history of alcohol or substance abuse, or inability to cooperate due to psychiatric disorders.
• NYHA class III-IV heart failure or hospitalization for worsening heart failure in the past 3 months, stroke or acute coronary syndrome in past 3 months, severe anemia (Hb < 60 g/L), severe liver or renal disease (ALT ≥ 3×upper limit; eGFR <30 mL/min/1.73 m2 or dialysis), systemic inflammatory response syndrome (SIRS), poorly controlled diabetes (FBG ≥ 13.3 mmol/L), severe obesity (BMI ≥ 35 kg/m2), untreated aneurysm, or other conditions severely interfering with study participation.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

456 participants in 3 patient groups

sequential combined AVS

Experimental group

Description:

non-ACTH-stimulated followed by ACTH-stimulated AVS

Treatment:

Diagnostic Test: sequential combined AVS

non-ACTH-stimulated AVS

No Intervention group

Description:

non-ACTH-stimulated AVS

ACTH-stimulated AVS

No Intervention group

Description:

ACTH-stimulated AVS