Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07298954

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

Led by Shumin Yang · Updated on 2025-12-24

456

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

Sponsors

S

Shumin Yang

Lead Sponsor

F

First Affiliated Hospital of Kunming Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully understand the study process, voluntarily agree to participate, and sign informed consent.
  • Diagnosed with primary aldosteronism.
  • Age 18 to 70 years with hypertension, any sex.
Not Eligible

You will not qualify if you...

  • Patients eligible for direct medical therapy or surgery without AVS due to typical biochemical and imaging findings.
  • Refusal of AVS or surgery, or contraindication to surgery.
  • Allergy to ACTH or contrast agents.
  • Presence of autonomous cortisol secretion (dexamethasone suppression test cortisol  50 nmol/L).
  • Early-onset hypertension (<20 years) with hypokalemia and family history suggesting familial hyperaldosteronism or Liddle syndrome.
  • Imaging unable to exclude pheochromocytoma or adrenocortical carcinoma (large nodules or suspicious MRI/CT findings).
  • Active malignancy.
  • Previous adrenal surgery.
  • Chronic glucocorticoid use that cannot be stopped.
  • Adrenal insufficiency requiring hormone replacement.
  • Pregnancy or breastfeeding.
  • History of alcohol or substance abuse, or psychiatric disorders preventing cooperation.
  • Severe heart failure (NYHA III-IV), recent stroke or acute coronary syndrome.
  • Severe anemia (Hb < 60 g/L).
  • Severe liver or kidney disease (ALT  3x upper limit, eGFR <30 mL/min/1.73 m2 or dialysis).
  • Systemic inflammatory response syndrome.
  • Poorly controlled diabetes (FBG  13.3 mmol/L).
  • Severe obesity (BMI  35 kg/m2).
  • Untreated aneurysm or other severe conditions interfering with participation.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affilated Hospital of Chongqing Medical University

Chongqing, China

Actively Recruiting

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Research Team

S

Shumin Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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